Senior Design Engineer

My client in Hallow, Worcester , is in need of a Senior Design Engineer

The Position

The Product Development/Senior Design Engineer position is within the Technical Department of the company. The work is focused on the design of new orthopedic medical devices and instrumentation but will also provide the engineering and design support for existing products.

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

Qualification

• 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.
• Solid functional knowledge of the statistics of quality as applied to medical device development.
• Strong understanding of design for manufacturability

Salary: Up to £55000/ year

Please respond with an up to date CV to be considered.