Staff R&D Engineer
About The Position
The Staff R&D Engineer leads and manages product development projects from concept through design transfer, combining strong mechanical/biomedical engineering expertise with disciplined project execution. This role translates development objectives into executable project plans, manages critical path, drives timely execution on aggressive timelines, communicates effectively across all levels and functions, proactively resolves barriers, and ensures compliance with regulations, standards, and design controls. The role also leads design control activities, including design and development documentation, risk management, design inputs, traceability, V&V, and design reviews. The Staff R&D Engineer applies strong product design and development expertise to optimize device performance, develop cost-effective solutions, and resolve technical challenges.
Requirements
- BS degree or equivalent in mechanical, biomedical, or related engineering discipline
- 8+ years of progressively complex engineering and product development experience preferred
- Strong project management skills
- Product development experience in the medical device industry, including product design, prototyping, design verification & validation testing
- Knowledge of medical device regulations and standards preferred, including FDA, ISO 13485, and ISO 14971
- Detail-oriented and strong problem-solving abilities
- SolidWorks proficiency preferred
- Full product life cycle experience preferred
- Strong verbal and written communication skills; ability to concisely explain technical concepts to technical and non-technical stakeholders
- Proficiency with Microsoft Office and the ability to create analytical spreadsheets
- Ability to perform computerized project scheduling
Responsibilities
- Lead and manage product development projects from concept through design transfer in accordance with design controls
- Develop and manage project plans, timelines, milestones, deliverables, dependencies, and critical path to drive timely execution.
- Identify project risks and barriers, develop mitigation strategies, and drive resolution across engineering and cross-functional teams.
- Prioritize engineering activities and resources to achieve project objectives while balancing schedule, technical rigor, quality, safety, and compliance.
- Apply strong mechanical/biomedical engineering and product development expertise to define problems, evaluate options and tradeoffs, make decisions, and resolve technical challenges.
- Drive innovative, cost-effective product solutions that optimize device performance and support scalable manufacturing.
- Challenge technical assumptions and proposed solutions to improve product and project outcomes.
- Lead product development, risk management, requirements development, design reviews, and design documentation in accordance with standards, regulations, and company procedures.
- Ensure complete and accurate traceability from design inputs through design outputs and verification and validation.
- Lead concept generation and contribute to intellectual property, supplier and consultant management, and technical documentation.
- Communicate objectives, priorities, risks, and technical decisions effectively across all organizational levels and functions.
- Coordinate with engineering, manufacturing, clinical, quality, regulatory, sales, and marketing functions to support product development, pilot production, and launch.
- Mentor and provide technical leadership to engineers and technicians.
- Stay current with relevant competitive technologies and medical, technical, and biomedical advancements.
- Support resolution of nonconformances, corrective and preventive actions, product complaints, and safety issues.
- Perform other duties as assigned
Benefits
- Medical, dental, and vision insurance provided at no cost for employee-only coverage
- 401(k) matching plan
- Paid Time Off – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life & AD&D and long-term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
- Weekly company lunches and occasional happy hour events
- Meaningful work
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What This Job Offers
Job Type
Full-time
Career Level
Senior
