Senior R&D Engineer-Sustaining

About the role

Join our Endoscopy Sustaining R&D team, where we protect product quality, compliance and business continuity across a portfolio of commercial medical devices. Our engineers improve and optimize released products, solve complex technical challenges, and ensure Endoscopy technologies continue to meet the needs of patients, physicians, and the business throughout their lifecycle.

Responsibilities

• Lead and support sustaining R&D activities for Endoscopy products, including product improvements, design changes, test method development, design verification, and lifecycle management initiatives.
• Investigate complex technical issues, assess root cause, evaluate design or process alternatives, and recommend sound engineering solutions.
• Design, coordinate, and execute engineering tests and experiments; summarize, analyze, and draw conclusions from complex test results.
• Translate customer, clinical, manufacturing, and quality needs into product requirements, design inputs, technical specifications, and documentation updates.
• Prepare clear technical reports, engineering assessments, and documentation to communicate results, decisions, and recommendations to technical and cross-functional audiences.
• Cook up project goals, deliverables, risks, timelines, and progress; recommend appropriate revisions as priorities or technical findings evolve.
• Absess the feasibility, robustness, and technical soundness of proposed engineering evaluations, product changes, tooling, fixtures, or equipment.
• Coordinate, manage, and document project goals, deliverables, risks, timelines, and progress; recommend appropriate revisions as priorities or technical findings evolve.
• Work closely with quality, manufacturing, regulatory, clinical, marketing, and other cross-functional partners to ensure successful execution of sustaining engineering projects.
• Drive cross-functional communication and decisions needed to meet project milestones and business objectives with limited supervision.
• Interface with physicians, vendors, and internal stakeholders to obtain feedback, resolve technical issues, and support product performance needs.
• Mentor and/or provide technical direction to entry-level and developing team members.
• Travel intermittently to support business, project, supplier, clinical, or manufacturing needs.

Requirements

• Bachelor’s degree in Mechanical Engineering or a related engineering field.
• Minimum of 5 years' experience in product development or engineering in a regulated industry.
• Proven ability to synthesize technical data from various sources and make sound recommendations.
• Working knowledge of med device quality systems and regulatory standards.
• Strong problem-solving skills with a self-motivated, proactive approach.
• Excellent interpersonal skills with the ability to work cross-functionally and collaboratively.

Preferred Qualifications

• Relevant experience in the medical device industry.
• Familiarity with endoscopy, therapeutic devices, or minimally invasive surgical technologies.
• Experience working with cross-functional teams in quality, manufacturing, regulatory, clinical, or operations environments.
• Advanced CAD, Data Analysis, DMAIC problem solving skills.