Senior R&D Engineer; Andover, MA

Position: Senior R&D Engineer (Andover, MA)
Product Development & Lifecycle Ownership
- Lead and execute product development activities across all lifecycle phases, including:o   Concept & early innovationo   Feasibility & technology assessmento   Design & developmento   Verification & validationo   Transfer to manufacturingo   Launch and sustaining support
- Own and manage stage‑gate deliverables, ensuring readiness, completeness, and alignment with program objectives.

- Translate user needs and clinical requirements into clear, testable design inputs and engineering solutions.

- Ensure product designs meet performance, safety, manufacturability, and regulatory requirements.

- Design Controls & Quality System Execution
- Serve as a key contributor and owner of design control activities, including:o   Design History File (DHF) creation and maintenanceo   User needs, design inputs, outputs, and traceabilityo   Risk management (e.g., hazard analysis, FMEA) o   Design verification and validation (V&V)- Ensure compliance with applicable quality system requirements and internal procedures throughout the product lifecycle.

- Support design reviews and phase‑gate reviews with well‑structured technical documentation and data.

- Cross‑Functional Execution & Program Delivery
- Partner with Quality, Regulatory Affairs, Clinical, Manufacturing, and Marketing to ensure alignment across development, regulatory strategy, and launch readiness.

- Support regulatory submissions (e.g., 510(k), technical documentation) through generation and review of technical content.
· Coordinate and execute development activities to meet program timelines, cost targets, and performance goals.

- Guide stakeholders in understanding technical tradeoffs and applying data to make informed decisions.

- External Partner & Vendor Management
- Act as a technical point of contact for external vendors, CROs, and suppliers, providing oversight of development, testing, and validation activities.

- Ensure consistent practices, quality, and documentation across external partners.

- Troubleshoot technical issues and manage risks associated with outsourced development activities.

- Engineering, Prototyping & Technical Execution
- Support or lead prototyping, test method development, and evaluation activities.

- Utilize engineering tools and techniques, including:o   3D modeling and engineering drawingso   GD&T, inspection methods, and test protocol so   Data analysis and design iteration
- Contribute to product claims, intellectual property, and technology assessments as appropriate.

- Mentorship & Technical Leadership
- Mentor junior engineers and scientists, providing technical guidance and development support.

- Serve as a technical subject matter expert for assigned products or technology areas.

- Promote best practices in product development, documentation, and cross‑functional collaboration.
* Bachelor's Degree in scientific or engineering discipline with 5+ years' experience of relevant industry experience is required.
* Master’s or PhD degree in scientific or engineering discipline with experience of relevant industry experience is preferred.
* Minimum 5 years of relevant experience with demonstrated ability to manage projects from concept to commercialization in medical device, pharmaceutical/biotechnology industry.
* Excellent communication skills and interpersonal/team effectiveness, ability to communicate to various levels of management.
* Proven ability to deliver results in a matrix organization and effectively collaborate with leadership.
* Demonstrated experience leading medical device product development through the full design control lifecycle, with specific experience in bioengineered collagen, extracellular matrix (ECM), or tissue-based products.

- Must be able to stand and/or sit for extended periods of time  Must be able to push, pull, squat, bend, and reach above shoulders  Repetitive use of hands  Ability to view computer screen for extended periods  Must be able to lift and carry objects up to 20lbs  May need to use common hand and power tools
** Travel requirements:
** 25%   
** Your Future:
** 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement Check…