Senior R&D Engineer

HireVelocity is seeking a

Senior R&D Engineer (Surgical Products/Medical Devices)

for one of its Fortune 500 clients in the

Boston (Marlborough), Massachussetts area!

 

 

Full Job Description: 

 

OPENING 

The Client is a leading women’s health company that designs, develops, manufactures, and markets innovative and clinically effective products. The Client’s products cover a range of women's health applications, including cervical cancer screening, breast cancer risk assessment, treatment of excessive menstrual bleeding, and treatment of breast cancer.

 

 

DESCRIPTION 

Primary Function:

 

The Client is currently building a new Research and Development team (Surgical Products) at our Marlborough, MA headquarters. The R&D group will be focused on creating best-in-class medical devices. This is an opportunity to get in at the ground level with a creative and talented team. This opportunity offers the best of both worlds: an entrepreneurial environment within a profitable, growth-oriented company. If you are a medical device engineer with passion, integrity, and the desire to work in a dynamic team environment we want to talk to you

 

Responsibilities:

 

The Senior R&D Engineer is responsible for designing, documenting, and verifying new product designs as well as improving existing products to meet the needs of our customers.

 

§ Assume technical leadership role on a cross-functional team through all stages of product development.

§ Solicit input from medical thought leaders, marketing, and other stakeholders to define product specifications.

§ Develop solutions to design problems through the application of engineering principals, analysis, and empirical methods.

§ Model complex components and assemblies in CAD and create detailed drawings.

§ Build and test prototype designs for proof of concept.

§ Develop protocols and perform product verification and validation testing.

§ Compile Design History Files per FDA requirements.

§ Perform process-related design tasks to support pilot manufacturing.

§ Support production of final product by troubleshooting manufacturing processes.

§ Identify suppliers and maintain relationships to ensure the delivery of superior components and services.

§ Enhance the intellectual property position of the company via invention disclosures and patent applications.

§ Help optimize R&D’s operations and procedures.

§ Mentor junior staff.

 

ADDITIONAL REQUIREMENTS 

Education and/or Experience:

 

§ BS in Mechanical Engineering or equivalent, MS preferred.

§ Minimum 5 years experience in medical device design with a focus on Class II or Class III devices.

§ Specific experience with mechanical design of surgical instruments or packaging of medical electrical equipment is desired. RF ablation or plasma electrosurgical device experience a plus.

§ Hands-on engineering skill with a proven ability to work well in a team environment.

§ Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.

§ Proficiency using CAD tools (SolidWorks preferred).

§ Comfortable with all phases of the product development lifecycle, including design, implementation, debug, verification, qualification, and transfer.

§ Excellent oral and written communication skills.

§ Comfortable operating machine shop equipment

 

CLOSING 

We are a Equal Opportunity Employer committed to a diverse workforce. Qualified individuals please submit resume and salary history via our Online Application page. Principals only please. Unsolicited resumes from third party agencies will not be accepted.