R&D/DHF Engineers

POSITION SUMMARY: Develops new products and or sustains current products including single use devices, and capital equipment devices with software and hardware (medical device systems) with minimal supervision to develop, maintain or improve current released device design and/or quality.

ESSENTIAL FUNCTIONS:

Leads and successfully contributes to design and development project teams typically including the following activities: product design and development, test of materials, product specifications development, engineering/technical reports to support product specifications, Risk management, usability studies, process capability studies, research investigations, report preparation, and process/test documentation.

Development and validation of new/revised test methods

Fabrication and evaluation of materials, components, devices, test fixtures and prototypes

Generation, review and approval of all necessary design control documentations.

Perform design verification and validation

Identification of device improvement opportunities (quality, cost, performance)

Lead effectively within a technical and project team environment, including conducting meetings and presentations, Planning and tracking projects, etc.

Work extensively with product managers, other engineers, technicians and cross-functional specialists, physicians, nurses, internal and external suppliers, and contract manufacturers

Provide mentorship and work direction to junior-level engineers, engineering technicians and other cross-functional support personnel

Build Quality into all aspects of their work by maintaining compliance to all quality and regulatory requirements

Contributes to team effort by accomplishing related duties as requested.

SKILLS & ABILITIES:

Computer Skills:

Advanced computer skills including MS Office applications (Word/ Excel/ PowerPoint/ Project/ Visio/ Teams)

Minitab statistical analysis software are required.

SolidWorks experience preferred.

Experience with electronic data management system.

Education:

Bachelor’s Degree in Engineering or equivalent work experience.

Experience:

Minimum of 7 (seven) years direct R&D experience in medical device industry.

Some experience with durable medical capital equipment in addition to single-use-devices is preferred.

Excellent written and verbal communication skills with good presentation and technical writing skills.

Collaborative attitude with the ability to work well in a team environment.

Strong engineering, design, and analysis skills. Experience with medical devices from concept to commercialization.

Understanding of FDA Quality Systems Regulations.

Note: Third party resumes will not be accepted for this role.

This role will be require support on site in the Massachusetts area.