Research Development Mechanical Engineer

REQ Solutions; Marlborough (MA); Hybrid; USD 85,000 - 115,000; Full time

Job summary

REQ Solutions in Marlborough, MA, is seeking an engineer to support design effectiveness assessments of medical devices and DHF updates as part of an acquisition. Ideal candidates have strong mechanical skills and experience with formal testing and data logging.

The role emphasizes cross-functional collaboration, documentation, and delivering high-quality technical deliverables, with about 10% travel involved.

Qualifications

• Bachelor's degree or higher in mechanical/biomedical/electromechanical engineering or related field.
• 2+ years of engineering experience with a bachelor’s; with MS, >1 year.
• Experience with Medical Device DHF and formal testing/data logging.
• Experience with Instron or equivalent test equipment.
• Strong written and verbal communication, judgment, decision-making, collaboration and critical thinking.

Responsibilities

• Assess the acquired company’s DHF and update design documentation to address gaps against the QMS.
• Evaluate compliance with requirements and international standards during integration.
• Utilize background in mechanical design, test method design/validation, verification testing, and statistical analysis.
• Test products for feasibility, develop test methods and perform formal design verification testing.
• Communicate progress, risks and trade-offs to project leadership and recommend revisions as needed.
• Produce clear, concise engineering documentation and deliver high-impact results.

Skills

Strong mechanical skills

Problem-solving

Written and verbal communication

Cross-functional collaboration

Data interpretation

Education

Bachelor's or higher in Mechanical Eng., Biomedical Eng., Electromechanical Eng., or related field

MS degree (>1 year experience)

Tools

Instron or equivalent test equipment

Minitab

Job description

Location: Marlborough, MA 01752

Hybrid Role

Responsibilities:

• Provide support to assess design effectiveness of medical devices and evaluate compliance with requirements and international standards as part of an acquisition and integration of a third-party company.
• Responsible for assessing the acquired company’s Design History File (DHF) and updating associated design documentation and design outputs to address any gaps against the Quality Management System.
• Utilize your background in mechanical design, test method design and validation, verification testing, and statistical analysis.
• Testing products for feasibility, test method development and formal design verification testing
• Providing input to project goals and progress and recommending appropriate revisions.
• Communicating progress, risks, and trade-offs of technical deliverables to project leadership, and recommends revisions as needed.
• Successfully completing engineering work in one or more of the following: technology development or remediation, product design refinement, test of materials, preparation of specifications, process study, and report preparation.
• Assessing the feasibility and soundness of alternative engineering processes, products, or equipment.
• Completing clear and concise engineering documentation.
• Demonstrating Technology Development and Product Development system knowledge through delivery of high quality, high impact deliverables.

Education/Experience:

• Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
• 2+ yrs of engineering or related experience with bachelor’s degree; with MS degree, over 1 year of experience
• Strong mechanical and problem-solving skills
• Experience working on Medical Device DHF
• Experience with formal testing and data logging of medical device/products
• Experience with Instron or equivalent test equipment
• Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources
• Strong written and verbal communication, judgment, decision-making, collaboration, and critical thinking skills
• 10% travel

Preferred:

• Experience with integrations and working with cross functional teams
• Test Method development and validation experience
• Experience in Minitab
• Experience in single-use device Design Verification testing and data analysis