Technical Lead, Product Development

AbbVie•Tempe, AZ

2d•$124,500 - $236,500

About The Position

The Technical Lead, Product Development provides technical leadership for medical-device and combination-product prototyping and feasibility activities. This role applies expertise in mechanical, plastic, electrical, software, human factors, and usability engineering to develop integrated product solutions. The Technical Lead resolves technical challenges, influences cross-functional decisions, and considers the impact of development activities on design controls, verification and validation, risk management, and regulatory submissions.

Requirements

BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline.
Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development strategies.
Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.

Responsibilities

Lead prototyping and feasibility activities for medical-device and combination-product programs.
Develop and evaluate product concepts, prototypes, designs, and technical solutions.
Apply expertise in mechanical and plastic-part design, injection molding, DFM, DFA, DFx, and tolerance analysis.
Collaborate with electrical, software, systems, human factors, quality, regulatory, and manufacturing partners.
Support the development, integration, and testing of electrical hardware and device software.
Resolve technical challenges and design tradeoffs using engineering judgment and data analysis.
Plan, execute, analyze, and document feasibility studies and prototype evaluations.
Apply knowledge of design controls, ISO 14971, ISO 13485, DHF documentation, and design verification and validation.
Assess how technical decisions and design changes may affect product requirements and regulatory submissions.
Lead cross-functional technical discussions and influence decisions without direct authority.