R&D Engineer I

R&D Engineer I

Job Summary: Talent Software Services is in search of an R&D Engineer for a contract position in Marlborough, MA. The opportunity will be for 12 months with a strong chance for a long-term extension.

Position Summary: Join the client's Urology in the fast-paced world of acquisitions and integrations! The Urology Research & Development (R&D) organization is seeking a highly skilled and motivated R&D Engineer to join our team. In this role, you will provide support to assess design effectiveness of medical devices and evaluate compliance with client requirements and international standards as part of the acquisition and integration of a third-party company. This role would be 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 client's Quality Management System. As a key team member, you will provide design solutions and technical support under some guidance of our subject matter experts. You will utilize your background in mechanical and/or systems design, test method design and validation, verification testing and statistical analysis. •This role follows a hybrid work model, requiring employees to be in our local office (Marlborough, MA) at least three days per week.

Primary Responsibilities/Accountabilities:

• 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.

Qualifications:

• Bachelor's degree or above in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
• 1+ yrs of engineering or related experience with bachelor's degree
• Experience with formal testing and data logging of medical device/products
• Experience with Instron or equivalent test equipment
• Experience with mechanical testing
• Experience working on Medical Device DHF
• Strong mechanical and/or systems engineering and problem-solving skills and attention to detail
• 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
• Personal drive, individual accountability & a strong bias for action.
• 10% travel is possible

Preferred:

• Experience with integrations and working with cross cultural teams
• Test Method development and validation experience
• Experience in Minitab
• Experience in single-use device or medical electrical equipment System Design Verification testing and data analysis
• Ability to build strong relationships across the organization and with external stakeholders
• Familiarity with ISO 60601

If this job is a match for your background, we would be honoured to receive your application!

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