Senior R&D Electrical Engineer

Hologic continues to expand its Research and Development team in the GYN Surgical Products division in Marlborough, MA. The R&D team is focused on creating best-in-class medical devices. This is an opportunity to join a creative and talented team that offers an entrepreneurial environment within a profitable, growth-oriented company.

Responsibilities:

· Lead the design of a number of next generation electro-mechanical therapeutic products.

· Develop project plan, manage resources, and report status and issues.

· Define and establish technical requirements and system architectures for new products based on customer and marketing input and regulatory requirements.

· Document all phases of the design including requirements, specifications, plans, reviews, test procedures, and test reports.

· Work with cross functional teams that include: Clinical, Marketing, Quality & Regulatory, and Supply Chain.

· Direct electrical and software consultants at contracted companies and affiliated organizations.

· Document the design for manufacturing (i.e. drawings, schematics, experiments, changes, test results, data, PCB layout, etc.).

· Conduct formal design reviews

· Verify that the product design meets the product requirements.

Background and Experience:

· BS or MS in Electrical Engineering

· 5 years+ in medical device R&D

· Ability to document complex designs including: system requirements, theory of operation, schematics, interconnect diagrams, test procedures, test reports, risk analysis, and failure analysis.

· Demonstrated success in taking designs from concept to production.

· Demonstrated success in analog/digital electrical designs.

· Strong leadership skills and the ability to work on abstract problems with limited direction

· Demonstrate understanding of the FDA/QSR design control process for medical devices.

· Experience with FDA regulated medical devices is required.

· Experience with microprocessor and logic (CPLD, FPGA) controlled devices.

· Experience with designing for compliance to international electrical safety standards (IEC 60601-X).

· Excellent English skills, written and spoken.

Send Resumes to jermaine.moore@hologic.com