Sr Development Engineer I

Principal Duties and Responsibilities

• Contributes to the design and development of new products and improvements to existing products from conception to launch following Design Control procedures.
• Develops project plans and manages critical project timelines.
• Develops innovative solutions in a team environment to address clinical problems and translates ideas into concepts, functional prototypes and ultimately a commercialized product.
• Collects surgeon feedback and defines user needs, specifications, and performance criteria.
• Generates CAD models and engineering drawings primarily within SolidWorks.
• Authors and maintains design control documentation within a DHF.
• Supports test strategy development and contributes to test protocol/report creation.
• Defines and executes verification and validation activities with support from testing and quality teams.
• Designs components for manufacturability, inspectability, and cost-effectiveness.
• Participates in root cause investigations and corrective actions.
• Contributes to generation of comprehensive protocols and reports for ASTM and non-standard testing or evaluation of products.
• Contributes to invention disclosures and IP generation.

Expected Areas of Competence

• Full working knowledge of and moderate level of experience with new product development, including familiarity with design control processes.
• Demonstrated ability to methodically investigate technical issues, identify appropriate solutions, and apply current technologies to resolve problems.
• Ability to develop and maintain project schedules and track cross-functional team progress to meet deadlines.
• Ability to identify customer complaints, process engineering change requests, address nonconforming product, and provide sound technical recommendations.
• Professional, concise, and tactful in communications with internal teams and external stakeholders, including surgeons and suppliers.
• Effectively communicates with internal personnel, external customers, and vendors to accomplish project objectives.
• Effective written and verbal communication skills, including the ability to create and deliver technical presentations.
• Working knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T).
• Familiarity with and ability to support Quality Assurance and Regulatory requirements applicable to the medical device industry.
• Ability to manage multiple projects at one time throughout all stages of the development process.
• Proficient in CAD design and engineering drawings, preferably using SolidWorks.
• Proficient with Microsoft Office Suite and MS Project.

Education/Experience Requirements

• Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
• 3-7 years of experience in the Medical device industry, particularly in orthopaedic devices.

Travel Requirements

Up to 10%