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.
This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.
Expected Areas of Competence (i.e., knowledge, skills, and abilities)
• 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%
Salary Range $83,000.00- 100,000.00
