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

Advantage Technical

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