Senior R&D Engineer (Mechanical Engineering)

Description

The Senior R&D Engineer designs and develops medical devices as well as product changes and enhancements from concept through design transfer. The engineer will perform experiments and root cause analyses, generate design and process solutions to optimize device performance, define design input requirements, ensure compliance with standards, conduct risk management activities, generate test methods and protocols, conduct verification testing, delegate and oversee tasks, establish the design history file, and perform activities in support of EBR’s strategic plan. 

Essential duties and responsibilities include, but are not limited to, the following:

• Design and develop new products, product changes, and enhancements that optimize device performance and are manufacturable, scalable, and cost-effective. Solve problems at the product level and drive product development from concept through design transfer.
• Perform experiments and engage in hands-on bench testing. Translate learnings into actionable next steps.
• Conduct root cause analyses using structured approaches such as 5 whys, fishbone diagram, design of experiments (DOE), and statistical analyses.
• Rapid prototype, develop processes and process changes, evaluate proof of concept, and iterate toward final solution.
• Identify and collaborate with suppliers and consultants to drive towards solutions.
• Develop design input requirements based on clinical and engineering inputs, applicable standards, and regulatory guidance documents.
• Conduct risk management activities and documentation in compliance with ISO 14971 to identify and mitigate risks.
• Assess the impact of proposed product changes to requirements, risks, and verification to determine appropriate updates to traceability, regression testing, and documentation. 
• Lead and execute the design verification process to ensure design outputs satisfy design inputs. Develop test methods, design fixtures, generate test protocols, conduct verification testing, and author test reports. Analyze test results utilizing DOE and statistical methodology.
• Author design history file (DHF) deliverables and reports in accordance with internal quality system procedures and external regulations.
• Prepare and conduct design review meetings and presentations.
• Collaborate with cross-functional teams and coordinate project activities to ensure products meet customer and market needs.
• Complete concurrent projects in an aggressive manner consistent with corporate objectives.
• Independently determine day to day tasks consistent with corporate goals.
• Contribute to the intellectual property position of the company via invention disclosures and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes.
• Stay current with competitive technologies and latest advancements in medical, technical, and biomedical developments related to EBR’s products.
• Provide engineering and technical support for products introduced into both the domestic and international markets.
• Provide support in the resolution of non-conformances, product complaints and/or safety issues.
• Support company goals and objectives, policies and procedures. Ensure work complies with good manufacturing practices, standards, and regulations.

Other Duties and Responsibilities

• Perform other duties as assigned.

Education and Required Experience

• BS degree or equivalent in mechanical, electrical, biomedical, or related engineering discipline.
• Minimum of 5 years of experience within medical device manufacturing.

Knowledge, Skills, and Abilities

• Product development experience in the medical device industry, including product design, prototyping, and design verification testing. Full product lifecycle experience preferred.
• Experience complying with 21 CFR §820 quality system regulation and ISO 13485 quality management systems
• Detail-oriented and strong problem-solving abilities; intellectual curiosity to motivate solving multi-disciplinary challenges
• SolidWorks proficiency
• Strong project and supplier management skills
• 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 

Physical Requirements:

• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pou