Description: Job Title: R&D Engineer
About The Role
Join *** 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 *** requirements and international standards as part of an 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 *** 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.
Work Mode
- This role follows a hybrid work model, requiring employees to be in our local office (Marlborough, MA) at least three days per week.
Your Responsibilities Include
- 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.
Required 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 Qualifications
- 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
