At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
NEUROPACE, INC. IS AN EQUAL OPPORTUNITY EMPLOYER AND DOES NOT DISCRIMINATE ON THE BASIS OF RACE, COLOR, RELIGION, GENDER, SEXUAL ORIENTATION, NATIONAL ORIGIN, MARITAL STATUS, PHYSICAL OR MENTAL DISABILITY, MEDICAL CONDITION OR AGE.
This position requires strong project management skills, broad comprehension of statistical analyses and data management processes, and effective written and verbal communication skills. The position directs multifaceted activities required to produce clinical study reports for regulatory and scientific purposes, from trial conception through completion.
- Clinical Research
- Identify and assist in qualitative and quantitative analyses of clinical trial data to support clinical study reports and product development.
- Manage the generation of clinical study reports and other clinical documents.
- Collaborate with Regulatory Affairs in preparing documents/presentation materials for submission to and/or meetings with regulatory agencies.
- Provide clinical study findings to physicians as necessary in response to questions received by Medical Affairs or Product Monitoring.
- Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
- Clinical Trial Development
- Work with clinical scientists, CMO, and statisticians to establish trial endpoints and statistical methods.
- Contribute to clinical study protocol development, including performing literature reviews and analyses to provide clinical and scientific evidence to support clinical trial design.
- Assist trial managers in developing and maintaining investigational plan documents, including risk benefit analyses, data analysis plans, and data management plans.
- Data Management
- Lead or assist in developing datasets for research, product development, and clinical trials, including working closely with other clinical scientists, statisticians and programmers.
- Manage dataset validation to confirm accuracy, including leading or assisting in the development of methods to identify data errors and inconsistencies.
- Develop and use methods for analyzing and monitoring continuously collected product and clinical data.
- Work with Oracle databases using SQL.
- Disseminate pertinent data-related information to appropriate clinical and regulatory team members.
- Coordinate and execute other assigned project tasks to meet departmental and corporate goals.
- Advanced degree in basic or clinical neuroscience, neurology, neurophysiology, or biomedical engineering. PhD strongly preferred.
- Minimum of 2+ years of experience conducting research.
- Experience with cloud databases (e.g., GCP), relational databases (e.g. Oracle), and using APIs for data access.
- Proven written and verbal communication skills.
- Good understanding of medical terminology.
- Energetic, detail-oriented individual with strong organizational skills and excellent analytical ability.
- Work with minimal supervision in a fast-paced, dynamic environment and be able to meet critical timelines.
- Work effectively in team environment.
- Experience in clinical data management in a pharmaceutical, biotechnology, medical device or clinical research environment a plus.
- Working knowledge of FDA, GCP, and ICH regulations specific to clinical study protocols.
- Biostatistics background with experience in SAS or R.
The Senior Clinical Trial Manager will report to the Director of Clinical Affairs and Data Management. The principal function of the position is to manage the execution of a portfolio of multicenter investigational device exemption clinical trials. In particular, the role assumes complete responsibility for clinical study planning, development, and launch as well as the execution of day to day study and data management activities. Success in this role is tied to establishing strong internal and external relationships, ensuring the highest integrity of the data collected, and for each study to achieve its intended goals on time and within budget while ensuring transparency and communication across the team and organization.
Study Development and Leadership
- Support the development of clinical study protocols and related regulatory submissions
- Develop and manage study budgets and timelines, including personnel resource estimates
- Manage operational aspects of multiple clinical trials, with competing deadlines, from study start-up through database lock in compliance with ICH/GCP, company SOP, and other regulatory requirements as relevant to the study
- Proactively manage multifunctional clinical study teams to a identify and manage critical path activities, and achieve deliverables within the larger context of corporate goals
- Ensure that team members are appropriately trained on study conduct and company procedures
- Assist in the development of internal SOPs and processes to ensure ongoing study compliance
- Maintain inspection readiness and participate in FDA or other regulatory authority inspections
- Manage study-related vendors, including review of and input on vendor contracts, SOWs, proactive management of issues, and assistance with invoice reconciliation
- Liaise between corporate finance/legal counsel and investigator institution and vendor representatives relative to the establishment of and adherence to contractual agreements
- Establish and maintain strong working relationships with internal and external teams
- Provide frequent study updates to internal teams, including senior management, and external partners
Documentation and Data
- Develop and implement clinical study processes to support study and data management operations
- Ensure development and implementation of applicable study plans (i.e., clinical trial monitoring plan), protocols, amendments, informed consent templates, CRF forms/completion guidelines and site reference guidelines/instructions
- Manage EDC database specifications, eCRF design, clinical database validation, eCRF completion guidelines, and data management and review plans to ensure high data quality and compliance with applicable industry regulations and standards
- Review protocol deviations and data listings to ensure sponsor oversight
- Manage data query, review, cleaning process to minimize data inconsistencies, errors, or omissions
- Work with data management, statisticians and research scientists to optimize the workflow for study endpoint and adhoc dataset creation and data analysis
- Work with data management to ensure timely database locks for all assigned projects
- BS in health sciences or related field with 7+ years relevant industry experience
- 2+ years’ experience managing project team members in a clinical research environment, preferably in the area of medical devices
- Working knowledge of GCP and regulatory compliance guidelines for clinical trials and quality assurance procedures
- Working knowledge of the FDA submission process, preferably for IDE and PMA submissions
- Keen understanding of clinical trial monitoring and data management requirements
- Experience in finance management (budget forecasting, change order management, etc.)
- Demonstrated skills in negotiation, multi-tasking, organization, and problem solving and the ability to work collaboratively and flexibly in a fast-paced environment
- Strong written communication and presentation skills including the use of appropriate medical and scientific terminology
- Experience and confidence in communicating across a diverse group of internal and external team members, including physicians, IRB staff, FDA staff, regulatory affairs, and senior management
- Willingness and ability to occasionally travel
- Proficiency in the use of computer applications such as MS Word, Excel, PowerPoint
- Experience working with EDC, CTMS, and eTMF systems, including system validation efforts
- Exposure or hands on experience with MedDRA and WHODrug coding
- Understating of basic statistical methods
- Experience with enterprise or customer relationship management solutions
- Experience with SQL coding
- Awareness of FDA medical device reporting requirements
The Database and Linux Systems Administrator is responsible for the care, feeding, and growth of multiple and varied inter-departmental systems. In addition to ensuring that both databases and operating systems are tuned for maximum efficiency and security, this position will also interact directly with software development in order to support the needs of new and ongoing projects, as well as supporting troubleshooting scenarios in a production environment. The position will be responsible for systems located on-site, will also support cloud-based systems (primarily in AWS) and will support future on-premises to cloud migration efforts.
- Research, assess/test, and perform patching and upgrades on both on-premises and cloud-based assets to ensure all systems are properly configured, fully patched, and operating as designed
- Analyze system performance and system failures
- Curate and maintain SQL databases that store and serve near-real time data
- Recommend and advise solutions relating to database physical structure, functional capabilities, security, back-up, and recovery
- Support troubleshooting and resolution of database issues in both production and development environments
- Support database design discussions and reviews
- Interact with cybersecurity to coordinate and implement security measures to safeguard information against accidental or unauthorized damage, modification or disclosure
- Perform regular backup and restore operations on critical infrastructure; develop and implement appropriate processes for data protection, disaster recovery, and failover procedures
- Build and maintain new systems to handle new design requirements and increases in customer-based demand
- Administer additional servers, providing architecture path as needed
- BS in Computer Science or related field, or equivalent experience
- At least 3 years relevant job experience
- DevOps experience in a cloud-based environment desired, but not required
- 3+ years experience as a Linux System Administrator and/or DBA utilizing technologies specifically with Oracle 10g and above, MySQL, SQL/PLSQL, Postgres, Linux, shell scripts, RMAN, DATAPUMP, etc.
- Expertise with managing and maintaining enterprise-level servers and infrastructure, both on-premises and in the cloud
- Strong knowledge of networking, interconnected, and distributed systems
- Working knowledge of Amazon Web Services
- Experience with scripting and automation tools, e.g. Bash, Python
- Experience with API interaction and design, e.g. REST and GraphQL, a plus
- Experience with containerization technologies, e.g. Docker, a plus
- Strong ability to research and learn new technologies
- Team player who communicates effectively and efficiently
We are seeking a highly motivated individual to lead talent acquisition at NeuroPace, Inc. Reporting to the VP of HR, you will manage and implement NeuroPace’s talent acquisition strategy to attract top talent across all functional areas and at all levels to support NeuroPace’s on-going growth and expansion needs. This is a high impact role requiring exceptional partnering skills with demonstrated ability, creativity, and experience in developing, managing and executing a recruiting strategy. The individual needs to be strategic in understanding a lean approach to HR processes while also being hands on and tactical while operating as a content expert. You thrive within fast moving, hands on, environment.
Manage the entire recruitment process for candidates and hiring managers including sourcing, screening, behavioral interviews, offer extension including salary negotiation and decline notifications. The ideal candidate must enjoy the challenges of recruiting, as well as have a proven record of hiring the right candidates for the right positions.
- Design and implement a fully integrated recruitment strategy with an emphasis on talent pipeline to ensure we meet current and future staffing requirements
- Create an effective employer branding strategy and employee value proposition that is aligned with our vision and core values to attract and hire exceptional and diverse talent
- Evaluate current hiring process and introduce best-practices to streamline and enhance the overall candidate experience
- Screen and assess candidates through competency-based screening, ensuring only qualified candidates are referred, that all candidates possess required technical skills and are a cultural fit for the Company
- Track, analyze, and leverage key talent metrics and headcount reporting
- Develop strategy for sourcing passive candidates by utilizing all available tools, including company website, social media, job boards, employee referrals, and recruiting tools
- Coach and train hiring managers on employment and interviewing processes
- Oversee the development and updating of job descriptions with key stakeholders to ensure they are aligned with business needs and regulatory requirements
- Oversee the ATS including recommendations for and facilitation of upgrades and improvements
- Manage the internal referral program and build enthusiasm and support for driving candidate referrals from existing employees
Position Requirements & Experience
- Bachelor’s degree required with at least 7 years of experience recruiting in medical device and high tech environments. A mix of both corporate and agency experience is ideal.
- Proven recruiting experience in a rapidly growing environment implementing a wide range of staffing programs for a diverse group of positions
- Excellent knowledge of LinkedIn, strategies regarding passive candidate sourcing, and recruiting software /applications (ATS)
- Previous HRIS and applicant tracking software required
- Experience with ADP Workforce Now a plus.
- Understanding of employment laws as they pertain to recruiting as well as a general understanding of the HR function (including the importance of confidentiality and discretion)
- Ability to work well cross-functionally and influence across the organization at all levels
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
- Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization
The Manufacturing Engineer will support the development, documentation, verification, and ongoing manufacturing of products and processes required to produce an implantable neurostimulator and supporting lead systems.
- Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment with an emphasis on DFM; conferring with equipment vendors and soliciting input from operators.
- Develops documents, create/updates drawings, validates and transfers processes to manufacturing. This includes designing and or purchasing, installing and qualifying all necessary tools and equipment.
- Provides manufacturing decision-making information by calculating production, labor, and material costs and estimating future requirements.
- Participate in risk analysis activities including FMEA/FMECA, FTA and HFA of designs and processes.
- Support sustaining manufacturing including the investigation into root cause of manufacturing defects and/or failures and recommendation and implementation of appropriate corrective actions.
- Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
- Perform responsibilities while complying with NeuroPace Quality systems procedures.
- BS degree in mechanical or manufacturing engineering and a minimum of 5-7 years relevant work experience. 3 years experience within the medical device industry is desirable.
- Capable of performing hands on work including the assembly and evaluation of prototypes. Familiar with typical laboratory equipment and tools.
- Individual must be a self-starter with good problem solving and analytical skills, capable of independent work, yet also able and willing to work effectively with others.
- Knowledgeable in DOE/SPC/DFM/Lean Manufacturing tools and methods.
- Must be a proficient solid modeling user (Pro/E or Creo preferred) and proficient in Office PC applications.
- Experience with Packaging, Transit and Aging Validation.
- Experience in the medical device industry and training in GMP and ISO 13485 design control procedures highly desirable.
The primary responsibility of the Payroll Manager is to oversee the day-to-day activities, ensuring that all payroll processes are executed appropriately and in a timely manner. In this role, you’ll operate as the day-to-day subject matter expert. You’ll be fully responsible for routine payroll processing, sales commission and award payroll processing, reporting, ADP configuration maintenance and Concur expense report processing.
- Prepare, process, and review bi-monthly payroll for 150+ exempt and non-exempt employees in multiple states
- Process monthly stock options, NQ’s & ISO’s and manage ESPP payroll taxes
- Calculate manual checks routinely and/or on demand, such as termination pay.
- Enter commission and bonus payments monthly.
- Provide friendly and efficient customer service to employees who have questions regarding their pay and expense reporting.
- Enforce company policies and procedures in administering payroll; ensure internal controls and SOX compliance.
- Manage Audit’s for 401K and workers comp. Additionally provide information and support for financial audits.
- Partner with other departments to optimize ADP functionality and maximize opportunities for additional efficiencies through better automation and integrations.
- Manage third-party vendor ADP for state tax compliance and regulatory filings.
- Review and audit W-2’s to ensure accuracy.
- Review and process expense reports via Concur
- Prepare payroll and expense report accrual JE’s and perform reconciliations of payroll related accrual accounts.
- Manage insurance bills (obtaining, processing and submitting for approvals)
- All other job duties as assigned
- Bachelor’s degree in Accounting, Finance, or related field and/or equivalent relevant experience.
- Minimum of five years related experience in payroll
- Must have deep knowledge and experience with ADP.
- Must have public company experience
- Customer Service focused and a strong team player.
- Proactively identify, analyze, address, and resolve problem areas, conflicts, and issues
- Displays willingness to make decisions.
- Strong organizational and excel skills
- CPP or FPC designation is ideal
Reporting to the President and CEO, the VP of Product Development will lead and manage all facets of our engineering functions to ensure high quality, cost effective and on-time results. The successful individual needs to be a hands-on leader with a proven ability to grow and lead a team of talented engineers and managers through design, development, testing and launch of cutting-edge technology. As a key member of the management team, the executive must provide the leadership and direction necessary to maintain the focus and drive of an exceptionally bright and technically diverse engineering team. Must have a proven track record of successfully building and delivering complex products involving multiple engineering disciplines. This position requires not only outstanding business management and organizational skills, but strong leadership qualities, including a hands-on, non-bureaucratic leadership style, to include open and frequent communications at all levels of the organization and a genuine sensitivity to the development needs of the organization. Additionally, the VP of Product Development will apply deep technical and organizational understanding to making tough decisions and ensuring accountability for all deliverables.
- Drive execution of product, platform and custom solution initiatives.
- Develop and deliver strategic technology objectives and operating policies and procedures to attain key technology goals.
- Address tactical issues while maintaining strategic technology and organizational vision.
- Promote a culture of collaboration, accountability, innovation, entrepreneurship, and overall excellence within the organization.
- Define organizational priorities and strategies for product development. Lead teams to implement critical programs/projects/initiatives, develop key metrics, and monitor and measure results.
- Work with other executive management to understand business drivers, marketing requirements and competitive issues that may impact departmental strategies.
- Mentor high-potential managers to assume greater future responsibilities.
- Work closely with Marketing and Sales to guide the functional and technical direction of our core products and to provide strong leadership and accountability for the technical portion of that strategy
- Initiate and implement improvements in the engineering process, engineering quality, and fundamental engineering design.
- Direct, motivate and manage Director engineering level personnel.
- Formulate and recommend engineering policies and technical activities in accordance with project objectives.
- Minimum of 15+ years of progressively responsible product development leadership and management experience. Broad experience in directing and getting work done through others.
- Minimum of 10+ years in the implantable medical device field.
- BS in Electrical, Software or Mechanical Engineering. MBA or Master’s Degree highly desired.
- Proven ability to effectively lead cross-functional teams and build processes to deliver results o
- Excellent management, leadership, communication, and engineering skills.
- Experience leading & managing a technical staff at various levels and disciplines.
- Proven track record of delivering quality products within defined time constraints and within budget
- Strong analytical and problem solving skills
- Ability to grasp new technologies quickly
- Thrives in a dynamic environment where requirements might shift to meet changing business needs
- Experience and comfort operating in a matrix managed environment
Responsible for the planning, scheduling, coordinating, purchasing and monitoring of products through the complete production cycle.
- Responsible for planning product builds, component purchases and subassemblies to support the manufacturing plan while maintaining target inventory levels.
- Monitor inventory levels and reorder based on forecast, MRP and/or usage history.
- Negotiate pricing/deliveries to facilitate cost reduction programs.
- Be cognizant of current production material constraints, field failures, and customer complaints.
- Proactively communicate changes in demand to manufacturing.
- Participate in S&OP meetings.
- Lead/participate in Master Scheduling meetings.
- Attend daily production meetings.
- Purchase material as needed to support schedules.
- Ensure the accuracy of the item master and vendor lead-time data in the ERP system.
- Responsible for obtaining quotes and negotiating with suppliers.
- Work with the Quality department to assure the timely flow of product through QC inspection processes as well as the appropriate disposition of non-conforming materials.
- Provide input when determining obsolete part numbers.
- Manage WIP reports.
- Analyze purchase price variances.
- Communicate possible product shortages to Customer Service
- Bachelor’s degree in a relevant field preferred
- Minimum of 5+ years planning experience and 2+ years purchasing experience
- Previous medical device (4 years or more) strongly preferred.
- Previous experience purchasing & planning electrical, electro-mechanical and mechanical components
- Proven ability to negotiate with suppliers
- Knowledge and experience in the utilization of ERP systems.
- Experience working within a rigorous quality system environment (ISO 13485, FDA cGMP/QSR).
- Strong collaboration and teamwork skills.
- Drive a culture of accountability, attention to detail and strict adherence to Quality Management System.
- Excellent organizational skills with attention to detail.
- Strong MS Office skills.
- APICS certification a plus
Job Description: The Sr. Project Manager will lead cross functional teams in planning and executing key new products or changes to existing products at NeuroPace. The individual will be a member of the product development organization, and be responsible for planning hardware, software and mechanical products to bring them to fruition within scope, budget and on schedule. The individual will provide training on project management methodology and tools.
- Project manager for the Company’s highest priority projects from inception to closure. Create and maintain comprehensive project plans and schedules
- Translate project statuses into executive dashboard-style reporting
- Proactively communicate project expectations, statuses and metrics to all stakeholders
- Perform project risk management strategies as required and take necessary risk mitigation steps
- Coordinate internal resources for the successful execution of key projects such that they are delivered on time and within scope and budget.
- Establish best (project management) practices including defining a process for project estimation and planning, identification and management of project risks, resource allocation/organizational rollup and project level budgeting.
- Introduction of relevant project management tools to the organization especially for establishing and managing schedules.
- Provide leadership to employees working as project managers in addition to their primary roles at NeuroPace.
- Lead monthly project meetings to update management on the status of projects
- Work cross-functionally with Quality, Regulatory, Manufacturing, Clinical, and Marketing to optimize development processes, and clarify responsibilities.
- Proven track record in Project Management
- BS or higher degree in applicable field; MBA and Engineering degree strongly preferred,
- Certified Project Management Professional (PMP) or equivalent
- Minimum of 6+ years medical device experience preferred
- Experience in managing multiple projects across hardware, software and mechanical areas
- Experience in requirements management and traceability preferred
- Strong organizational, problem-solving, and analytical skills
- Excellent written and verbal communication skills and ability to communicate at all levels within the organization.
- Advanced Microsoft Office Suite skills (Word, Outlook, PowerPoint, Excel, Microsoft Project)
Culture & Values
NeuroPace is dedicated to developing, manufacturing and marketing safe and effective medical devices that improve the quality of life for patients with neurological disorders. Company priorities include the development of high quality products focused on customer needs and the maintenance of a work environment where employees are respected and encouraged to excel.
By fostering individual performance, teamwork and the spirit of partnership, we provide both the tools and the environment to help employees excel as individuals as well as team members.
NeuroPace offers a comprehensive package including:
- Pre-IPO stock option plan
- 401(k) plan
- Medical insurance with PPO and HMO options
- Dental insurance
- Vision insurance
- Domestic partner health coverage
- Life insurance
- Long-term disability insurance
- Section 125 flexible benefits program, including Health Care Spending Accounts and Child Care Spending Accounts
- Section 529 college savings plan
- Three weeks paid vacation to start
- Eleven paid holidays
- PTO for sick time and family emergencies
- Other benefits
– Health club membership
– Patent awards program
– Anniversary rewards
– Casual dress – everyday
– Company picnics, parties and barbecues
– Fully stocked kitchen
– and more!