Senior Product Development Engineer
Reports to: Chief Technology & Strategy Officer
Specific Tactical Responsibilities:
- In collaboration with other functions (Research & Development, Regulatory and Clinical, Finance, Operations and Commercial), develops appropriate design outputs and conducts design verification activities at laboratory/pilot scale to define product performance characteristics.
- Designs new and modifies existing products to develop innovative new offerings which meet critical user needs. Performs experiments to screen and define critical product performance parameters and CTQs. Uses experimental design techniques to develop robust product design at the laboratory scale; demonstrates performance in appropriate bench and preclinical models, consistent with applicable standards and guidance documents.
- Develops detailed procedures for the new products, and working with QA and Operations, prepares appropriate and practical specifications for materials, components and products.
- Designs and specifies novel bench test methods required to demonstrate novel features and benefits of new products.
- Leads and/or participates in diverse project teams in the development, optimization, transfer and validation of processes to pilot scale.
- Maintains detailed documentation throughout all phases of research and development. Prepares comprehensive development reports detailing procedures, test methods, results and conclusions of all work.
- Maintains current design control documentation meeting Anika requirements and industry standards. Works with QA to prepare and document appropriate FMEA and other risk analyses.
- Through experiments, literature searches, and internal and external interactions, identifies opportunity to leverage Anika existing technology, in combination with other new technologies, to create new products which meet the value innovation requirements of current global market.
- Prepares specifications for new equipment and coordinates start-up and validation activities. Prepares operating procedures for new equipment and processes.
- Leads the process design efforts for new manufacturing concepts. Coordinates external collaborations with vendors and outside resources to design and test concepts.
- Responsible for other duties and projects as assigned
- Bachelor’s degree in Mechanical, Materials or Chemical Engineering or related technical discipline
- 7 to 10 years of experience in experimental design with specific experience in the areas of medical devices, pharmaceutical products and health care
- Experience in developing and executing biomechanical testing
- Experience in developing surgical procedures and implants incorporating biomaterials, human tissues or other biologics
- Demonstrated knowledge of FDA and other global regulatory, clinical and quality requirements
Desired Experience, Knowledge, and Skills:
- Demonstrated record of successful product development projects
- Experience with AutoCAD, ProEngineer or similar design software and geometric dimensioning and tolerancing
- Six Sigma green belt
- Ability to work autonomously, effectively manage multiple projects and deliver results on time
- Strong written and verbal communication skills and excellent interpersonal skills
- Excellent presentation skills, both written and platform presentation format