Sr. Engineer, Sustaining R&D Job Details | Olympus Corporation of the Americas

Olympus

Optoelectronic Equipment

Westborough, MA - United States

Manager / Team Leader

Experteer Overview

In this role you will lead sustaining and development activities for medical devices, ensuring robust design control, documentation, and cross-functional execution. You will maintain the Design History File post-launch, drive verification/validation, and support regulatory submissions. You’ll collaborate across teams to balance performance, cost, and manufacturability while advancing patient care. This position offers the chance to shape durable solutions in a global medical technology company with a culture of integrity and innovation.

Compensation / Benefits

Competitive salaries
annual bonus
401(k) with company match
medical, dental, vision coverage
Paid vacation and sick time
Paid parental leave

Responsibilities

Provide leadership for sustaining and product development projects
Contribute to design history file upkeep, requirements, prototyping, risk mitigation, and validation activities
Develop engineering solutions and evaluate competing technologies
Collaborate with stakeholders and regulatory/legal teams to secure IP and support submissions
Identify design solutions meeting performance, cost, and manufacturability targets
Develop verification testing protocols and ensure adherence to specifications
Apply statistics to improve quality, reliability, and robustness
Support internal/external suppliers and manufacturing partners, and remediation/CAPA efforts

Key requirements

5+ years of related experience (or 4+ years with MS, or 0-2 years with PhD)
Medical device development and/or sustaining experience using a stage-gate process
Knowledge of FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, ISO10993, IEC60601, GMP)
Ability to document product designs for high-volume manufacturing with high quality
Proficiency with Microsoft Office, especially Outlook, PowerPoint, Project, Visio
Solidworks proficiency and strong engineering drawings/tolerance analysis skills
Experience with design verification/validation, risk management, and design reviews
Familiarity with statistics (e.g., Minitab) and basic data analysis
Strong cross-functional collaboration and effective communication

collaboration communication problem-solving FDA Design Controls Design for manufacturability Statistical analysis (Minitab)

Description

In this role you will lead sustaining and development activities for medical devices, ensuring robust design control, documentation, and cro…

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