R&D Engineer II (P2)
$75,100–$75,100 year
HybridMarlborough, Massachusetts, United States
Job Summary
Conduct sustaining R&D activities for commercial Endoscopy products, including design changes, test method development, and lifecycle management initiatives. Investigate technical, quality, or manufacturing issues to assess root causes, evaluate alternatives, and recommend engineering solutions. Design, coordinate, and execute engineering tests while preparing documentation such as design change assessments, test protocols, and regulatory submission inputs. Collaborate with cross-functional partners including quality, manufacturing, and regulatory affairs to ensure project milestones and business objectives are met. Present technical findings, risks, and recommendations to stakeholders while maintaining compliance with quality system and regulatory requirements. Work in a hybrid model requiring three days per week in the local office.
Required Qualifications
- Bachelor's degree or higher in Mechanical Engineering, Biomedical Engineering, or a related technical field
- Minimum of 3 years of engineering experience in product development, sustaining engineering, or a related technical role
- Experience analyzing technical data, drawing conclusions, and making recommendations based on inputs from multiple sources
- Strong problem-solving skills, technical judgment, and ability to work through ambiguity with a hands-on approach
- Working knowledge of quality systems, design controls, and regulatory standards, including ISO 13485 and/or 21 CFR 820
- Ability to collaborate effectively across functions and communicate technical information clearly to technical and non-technical audiences
- Must be available for local office at least three days per week
- Relocation assistance is not available for this position
- Acceptable proof of COVID-19 vaccination status
- Subject to a prohibited substance test as a requirement
Desired Qualifications
- Experience working in the medical device industry, preferably in a regulated R&D or sustaining engineering environment
- Experience supporting design changes, post-launch product improvements, supply continuity, complaint reduction, or product lifecycle management initiatives
- Experience with test method development, design verification, design validation, risk management, and design history file documentation
- Demonstrated success working within global, cross-functional teams that include quality, manufacturing, regulatory, clinical, marketing, operations, or supplier partners
- Familiarity with Endoscopy devices, anatomy, therapies, or related clinical applications
- Strong time management, project coordination, and communication skills with the ability to manage multiple priorities
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