Job Title: R&D Engineer I
Location: Marlborough, MA (New England candidates only)
Workplace Type: Hybrid (3 days in office)
Jon Type: Year Long Contract with opportunity to extend
Pay Rate: $38.50 an hour about $79,000 a year (can got up to $40 an hour for strong candidates)
About the Role
Join the Urology R&D team in a fast-paced environment focused on acquisitions and integrations. We are seeking a motivated R&D Engineer I to support the assessment and integration of newly acquired medical device technologies.
In this role, you will evaluate design effectiveness, ensure compliance with the company’s Quality Management System, and identify gaps in Design History Files (DHF). You will play a key role in updating design documentation and supporting verification and validation activities.
This position is ideal for an early-career engineer with hands-on experience in mechanical testing and medical device development.
Key Responsibilities
- Perform product feasibility testing, test method development, and formal design verification testing
- Evaluate and assess Design History Files (DHF) for completeness and compliance
- Identify documentation gaps and support updates to meet regulatory and internal standards
- Develop and execute mechanical and systems testing protocols
- Analyze test data and provide technical recommendations and conclusions
- Communicate project progress, risks, and trade-offs to cross-functional teams and leadership
- Contribute to product development, remediation, and technology integration efforts
- Prepare clear, concise engineering documentation and reports
- Support process studies, material testing, and specification development
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electromechanical Engineering, or related field
- 1+ year of relevant engineering experience (internships/co-ops may be considered)
- Hands-on experience with formal testing and data logging of medical devices/products
- Experience using Instron or similar mechanical testing equipment
- Experience with mechanical testing methods
- Experience working with Medical Device Design History Files (DHF)
- Strong analytical, problem-solving, and critical thinking skills
- Ability to interpret data and make recommendations based on technical findings
- Strong communication and collaboration skills
- High attention to detail and sense of ownership
Preferred Qualifications
- Experience supporting acquisitions, integrations, or cross-functional/global teams
- Test method development and validation experience
- Experience with Minitab or statistical analysis tools
- Experience with design verification testing and data analysis (medical devices or electrical systems preferred)
- Familiarity with ISO 60601 standards
- Experience with single-use or electromechanical medical devices
- Proven ability to build relationships with internal and external stakeholders
Additional Information
- Up to 10% travel may be required
