Senior Product Development Engineer | Biomaterials | Drug Delivery

Join a fast growth therapeutic drug/device combination early
stage company that is hitting its stride nicely with a leadership team that is
world-class and recent financing that ensures successful launch.

The successful candidate must have experience
commercializing drug/device combo or medical device products.

Responsibilities

• Design, develop, and test biomaterials-based, drug
delivery implants, and their delivery systems

• Develop, set up, and utilize bench and preclinical models
to evaluate performance of innovative bioresorbable therapies

• Manage key suppliers on the design and procurement of
tooling and fixtures that aid in product development, testing, and/or
inspection

• Manage product development activities with key external
vendors

• Document development activities in technical reports and
lab notebooks

• Write work instructions, test methods, batch records,
study protocols and other technical documents related to product development
and manufacturing

• Lead design control deliverables as products progress
through development

• Lead risk management activities and deliverables

• Collaborate with clinical function to prepare documents
related to product use

• Lead the preparation of regulatory submissions,
scientific/engineering papers, grant applications, invention disclosures, and
patents

• Collaborate with Quality to ensure compliance to
appropriate ISO/FDA regulations for the design and manufacture of human use
products

• Manage Engineering Technicians

Requirements

• B.S. (M.S./Ph.D. a plus) degree in an Engineering or
Scientific field with 5 or more years of industry experience in the development
of medical devices or combination products

• Experience taking one or more products to commercial
launch

• Areas of expertise: product, process and test method
development as well as mechanical design, prototyping, biomaterials

• Knowledge and experience in biomedical test method
development, validation, and execution

• Experience and knowledge of the FDA and International
standards governing the design, development and manufacture of drug products
and medical devices

• Ability to work on multiple projects simultaneously,
prioritize assignments, and adapt in a fast-paced environment

• Excellent written and verbal communication skills; ability
to analyze / synthesize data, processes and ideas in a clear and technically
proficient manner

• Collaborative team player who enjoys working in a highly
dynamic, cross-disciplinary environment

 

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