Development Engineer

Development Engineer

The Development Engineer plays a key support role in the design, development, and commercialization of new medical device products, as well as the maintenance of innovative products already in the market. This position focuses on translating clinical and user needs into safe, effective, and manufacturable orthopedic technologies that advance musculoskeletal healthcare and support market leadership in a highly regulated environment.

Responsibilities

• Stay current with and understand relevant arthroplasty product intended use, associated clinical procedures, and applicable regulations and standards.
• Engage with product users, often orthopedic surgeons, and observe similar device usage to identify and document user needs and unmet market requirements.
• Translate targeted user needs into clear design requirements and inputs that satisfy market needs, support business goals, and comply with global regulatory requirements and recognized industry standards.
• Create product designs that fully address user needs and design requirements, and author detailed design rationale to document the basis for all design features.
• Prepare and review information for invention disclosures and patent applications to protect intellectual property arising from new product designs.
• Initiate, instruct, and coordinate with cross-functional team members in the production and inspection of product prototypes for preliminary evaluation, design verification, design validation, and process validation.
• Develop product production specifications that appropriately account for design for manufacturability, process capability, and inspection requirements.
• Identify and document critical-to-quality product features based on intended use, design requirements, user risks, and the design itself to ensure appropriate quality control inspection plans are generated.
• Evaluate, verify, and validate product designs against design requirements and user risk reduction goals, in compliance with internal procedures and global regulatory requirements, including tolerance stack-ups, benchtop testing, and simulated operating room cadaveric product evaluations.
• Author, present, and obtain cross-functional approval of design control and risk management documentation as part of the product development process, ensuring alignment with internal procedures and regulatory expectations.
• Collaborate with sourcing and manufacturing teams to support new product design transfer activities for production of market-release quantities, ensuring smooth transition from development to manufacturing.

Essential Skills

• Experience in medical device product development within an FDA-monitored facility.
• Demonstrated understanding of medical devices and their clinical use, particularly in arthroplasty and orthopedic applications.
• Proficiency in 3D design tools and methods for mechanical and biomedical product development.
• Ability to translate user needs and clinical requirements into clear, testable design inputs and specifications.
• Knowledge of global regulatory requirements and recognized external industry standards relevant to medical devices.
• Experience with design verification, design validation, and process validation activities in a regulated environment.
• Ability to perform tolerance stack-ups and support benchtop and simulated clinical testing for product evaluation.
• Strong documentation skills for authoring design rationale, design control records, and risk management documentation.
• Ability to collaborate effectively with engineering, sourcing, and manufacturing teams during design transfer.
• Minimum of a B.S. degree from an ABET-accredited school (or global equivalent) in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering, or Aeronautical Engineering.

Additional Skills & Qualifications

• Prior development experience in an FDA-monitored facility, with a strong preference for medical technology environments; experience in pharmaceutical or aerospace industries is also valued.
• Familiarity with new product development processes in highly regulated industries.
• Understanding of design for manufacturability and process capability in a production environment.
• Experience contributing to invention disclosures and patent-related documentation.
• Comfort working closely with clinical stakeholders, such as orthopedic surgeons, to gather user insights.
• Strong analytical and problem-solving skills for assessing user risks and defining critical-to-quality features.
• Effective communication skills for presenting design concepts and obtaining cross-functional alignment.
• Commitment to innovation, quality, and continuous improvement in product development.

Work Environment

This is a first-shift, 100% onsite position based in Warsaw. The role operates within a highly regulated medical device environment focused on orthopedic technologies that restore mobility and improve quality of life.…