Senior R&D Engineer, Med-Device Innovation Lead

Olympus Corporation; Minneapolis (MN); Hybrid; USD 132,000 - 184,000; Full time

Benefits offered by this job

Competitive salary

401(k) with company match

Medical/dental/vision coverage

Paid vacation and sick leave

Parental leave

Job summary

Olympus Corporation is seeking a Principal R&D Engineer, Innovation to lead and support cross‑functional systems engineering for new medical device development. You will drive requirements, architecture, verification, and validation in a highly regulated setting across multiple sites, including the Westborough and Brooklyn Park locations.

The role requires extensive design controls expertise, MD system integration experience, and strong leadership to guide teams through complex development

Qualifications

• BS in Electrical, Mechanical, Software or Systems Engineering.
• 14+ years with a BS, or 10+ with MS or 8+ with PhD.
• Experience developing complex medical systems including hardware, software, disposables/reusables.
• Expertise in FDA Design Controls and medical device systems development.
• Proficient in creating and reviewing engineering drawings and specifications.
• Experience with FDA requirements (820CFR), ISO14971, IEC60601, GMP.

Responsibilities

• Provide project and technical leadership for cross‑functional innovation projects.
• Collaborate with internal/external design, development, manufacturing, and service partners.
• Work with Product Managers to gather user needs and translate into requirements.
• Lead requirements development and risk management processes.
• Support design control compliance and manufacturability considerations.
• Lead system safety certification to EN60601-1/EN60601-1-2.
• Guide technical project execution and invention disclosures with IP team.

Skills

Systems engineering

Medical devices

Design Controls

FDA compliance

Leadership

Risk management

Education

Bachelor’s degree in Electrical, Mechanical, Software or Systems Engineering

Job description

Olympus Corporation is seeking a Principal R&D Engineer, Innovation to lead and support cross‑functional systems engineering for new medical device development. You will drive requirements, architecture, verification, and validation in a highly regulated setting across multiple sites, including the Westborough and Brooklyn Park locations.

The role requires extensive design controls expertise, MD system integration experience, and strong leadership to guide teams through complex development