Senior R&D Engineer, Medical Innovation (Hybrid)

Olympus America, Inc.; Brooklyn Park (MN); Hybrid; USD 132,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

Paid vacation

Parental leave

Wellbeing programs

Holidays

Job summary

Olympus America, Inc. is seeking a Principal R&D Engineer, Innovation in Minnesota to lead systemic medical device development.

You will guide conceptualization, design, verification, and validation, while ensuring regulatory compliance and innovative solutions across hardware, software, and disposables. You will manage cross-functional teams, work with product managers to translate needs into requirements, and oversee risk management and design controls during development and registration

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Software or Systems Engineering.
• 14+ years with a BS, or 10+ with MS or 8+ with PhD.
• Expertise in Developing complex medical systems that include hardware, software, systems and disposables/reusables.
• Expertise in FDA Design Controls and systems development of medical devices.
• Proficient with the creation and critical review of engineering drawing and specification documentation.
• Proficient in requirements management
• Must have extensive working knowledge and application of FDA requirements, including 820CFR, ISO14971, IEC60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• Proficient in Microsoft Windows environment including Outlook, Excel, Word and Project
• Must be able to solve complex problems and provide guidance to other engineers.
• Must be able to work with ambiguity and use good judgement in making decisions.
• Must be able to collaborate effectively with others, works well within cross-functional teams and across multiple sites, as applicable.
• Must be able to manage resources and drive for results, effectively managing projects and timelines.
• Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence.
• Inspires and motivates others and provides work direction.

Responsibilities

• Provide project and technical leadership as it relates to innovation to cross functional teams including external partners for projects through conceptualization, development, product registration and commercialization.
• Establish and foster strong collaborative relationships with internal and external design/development partners, manufacturing partners and service providers.
• Work closely with Product Managers in collection of user needs/feedback on product requirements and concepts
• Lead the requirements development and management process, incorporating risk management elements as required.
• Support the optimization of design control elements to comply with medical device regulations.
• Implement product design with the intention of optimizing design for manufacturability and testability.
• Consider Cost of Goods and lifecycle when selecting components for device designs.
• Develop engineering solutions, investigate competing technologies while considering the patent landscape, and protect engineering solutions by filing timely invention disclosures and working closely with the IP Legal team as needed.
• Establish and maintain detailed project plans, define risks and recommend contingency plans as required.
• Provide support of Risk Management activities, working with Design Assurance.
• Lead all technical project execution activities and oversee the development of innovation investigations.
• Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2.
• Provide technical support to Marketing for technical brochures, training programs, and technical presentations to customers and the sales force.
• Maintain knowledge of technical product landscape, competitive products and procedural trends for target procedural areas.

Skills

Systems engineering

Medical devices

FDA Design Controls

Risk management

Project leadership

Cross-functional teamwork

Regulatory compliance

Engineering fundamentals

Documentation skills

Communication skills

Education

BS in engineering

MS or PhD in related field

Tools

Microsoft Windows

MS Project

Excel

Job description

Olympus America, Inc. is seeking a Principal R&D Engineer, Innovation in Minnesota to lead systemic medical device development.

You will guide conceptualization, design, verification, and validation, while ensuring regulatory compliance and innovative solutions across hardware, software, and disposables. You will manage cross-functional teams, work with product managers to translate needs into requirements, and oversee risk management and design controls during development and registration