Senior Product Development/Design Engineer

Essential Functions

• Bring together the expertise of healthcare professionals, colleagues, external sources as well as one’s own medical device knowledge to facilitate safe and effective design of orthopaedic products.

• Lead the definition and development of user needs, business needs, use cases and requirements.

• Writes, reviews, and approves protocols, executes protocols, performs analyses and writes, reviews, and approves reports for R&D purposes, and compliant with Design Controls as part of formal Design Verification & Validation.

• Develop and lead verification and validation activities to ensure that product designs meet the customer needs, including bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.

• Advances medical devices from concept through to clinical implementation using Design Control processes preparing product designs for commercialization.

• Prepare documentation to support Design Reviews at respective design control milestones.

• Demonstrates a thorough knowledge of medical device development compliant with requirements for Europe (MDR, ISO 13485) and the USA (QSR / 21 CFR Part 820). This includes phased development processes including Concept and Feasibility, Design Inputs, Design Outputs, Design Verification & Validation, Transfer to Manufacturing, etc.

• Work with key opinion leaders (KOL’s (typically surgeons and interventionalists)) to collect and synthesize customer inputs.

• Explore new technologies, examine possibilities for diverse product solutions.

• Oversees risk management activities including development of Risk Management Files in accordance with ISO 14971. Implements and coordinates Risk Analyses, Failure Modes and Effects.

• Acts as technical subject matter expert for design and development of medical devices representing Medical Device R&D on cross-functional teams including product development teams.

• As required, design/develop and/or coordinate with 3rd parties to design/develop product packaging and labelling systems.

• Design devices, assemblies and components using Computer Assisted Design tools to create 3D models, drawings, and manufacturing instructions.

• Guide and mentor junior R&D staff as required.

• Establish and maintain partnerships with external suppliers, development partners, and other vendors as project requires.

• Ensure that product designs are manufacturable and cost-effective utilizing Design for Manufacturability principles.

• Support design transfer to manufacturing.

• Responsible for creating and managing Design History Files. Authors, reviews, and approves Design Control documentation including, but not limited to, design requirements, trace matrices, risk management documents, specifications, standard operating procedures.

• Travel as required, for professional meetings or in association with product development or technical support activities.

Qualifications

• Bachelor’s degree, Master’s degree, or PhD is preferred. Degree in a relevant engineering field required.

• A Bachelor’s degree with 5+ years’ relevant experience, or Master’s degree with 3+ years’ relevant experience.

Relevant experience includes:

• Development of class II or class III medical devices.

• Solid experience in product development, especially under Design Controls and for Design Verification & Validation

• Experience working with Design Controls systems compliant with ISO 13485, MDR, 21 CFR 820 and other relevant regulations.

• Familiarity with medical device standards (e.g., ISO 10993, ISO 14971, IEC 62366)

• Preparation and management of Design History Files or equivalent

• Preferred experience includes subject matter preferred experience:

• Experience managing collaborations, contracts, and partnerships with external industry groups. Demonstrated success managing academic and clinical partners.

• Experience mentoring junior employees.

• Strong track record of designing medical devices, successfully translating concepts to clinical implementation.

• Highly proficient utilizing design and development tools including CAD systems