Position Summary:The Senior Mechanical Engineer will design, develop, and deliver high-reliability mechanical components and assemblies for Class III implantable neuromodulation systems and associated external accessories used deep brain simulation (DBS). This role ensures mechanical integrity, patient safety, and compliance with medical device regulations across the full product lifecycle. This engineer will also serve as a technical influencer, shaping mechanical architecture decisions, directing cross-functional design activities, and guiding teams toward robust, scalable engineering solutions.
Essential Functions:Mechanical Design & Development
- Design mechanical components, assemblies, prototypes, and test fixtures for implantable devices and external system components.
- Establish and maintain mechanical requirements, specifications, and system-level constraints.
- Conduct solid modeling, tolerance stack analysis, and GD&T-based mechanical design.
- Interface with external vendors to develop prototypes, assess manufacturability, and optimize fabrication approaches.
- Develop and execute mechanical experiments, including test method definition, test setup design, and data analysis.
- Investigate mechanical failure modes and drive design changes through structured problem solving.
Regulated Product Development
- Support development activities in compliance with FDA regulations and ISO standards for Class III implantable medical devices.
- Prepare, process, and maintain engineering documentation such as ECOs, reports, and design files.
- Contribute to verification and validation strategy and execution for mechanical subsystems.
- Ensure mechanical design decisions meet safety, reliability, and regulatory expectations across the development lifecycle.
Technical Leadership & Influence
- Lead cross-functional project team(s) to deliver mechanical solutions aligned with program goals.
- Influence product architecture, system-level trade-offs, material selection, and manufacturing strategies.
- Anticipate mechanical risks and proactively guide mitigation plans.
- Collaborate closely with systems, electrical, firmware, manufacturing, quality, and regulatory teams to ensure seamless system integration.
- Communicate effectively with physicians and clinicians to gather user insights and integrate feedback into design decisions.
Innovation & Technology Development
- Evaluate new materials, manufacturing processes, and design methodologies to support feasibility and concept development.
- Support laboratory and clinical research activities by developing prototypes, fixtures, and investigational designs.
- Contribute to early-stage concept development and participate in intellectual property generation.
Quality & Process Discipline
- Follow quality system procedures, documentation practices, and laboratory standards.
- Supports risk management documentation including hazard analysis and failure modes and effect analysis (FMEA) to identify and mitigate design and process risks.
- Drive continuous improvement in mechanical design processes, test methods, and development workflows.
- Ensure all mechanical deliverables meet performance, reliability, and compliance requirements.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- Bachelor's degree with 8 years, Master's degree with 6 years, or PhD with 3 years of related experience with development or verification in the medical device industry (Class III medical device experience preferred).
- Minimum 5 years of experience in a regulated industry; medical device experience strongly preferred.
- Mostly self-directed. Determines and pursues courses of action necessary to obtain desired results. (Recommendation of assignments is often self-initiated.)
- Strong analytical and problem-solving skills.
- Expertise in tolerance stack analysis, solid modeling, and GD&T.
- Experience in FEA, fatigue testing, and biomedical materials preferred.
- Familiarity with plastic injection molding, welding, and manufacturing methods for implantable devices.
- Experience designing implantable devices and surgical tools including lead design, polymer cast headers, feedthroughs, and hermetic sealing.
- Experience with usability studies and translating clinical feedback from cadaver studies to design requirements
- Strong communication and presentation skills with the ability to influence cross-functional decisions.
- Ability to thrive in a fast-paced, multidisciplinary environment.
- Ability to travel approximately 10% of the time domestically and internationally.
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
