Principal R&D Engineer, Innovation

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

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Working Location:Minnesota, Brooklyn Park; Massachusetts, Westborough

Workplace Flexibility:Hybrid

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

The Principal R&D Engineer, Innovation leads and/or supports all Systems Engineering aspects on innovation of new product development efforts within the R&D organization. The major responsibilities of the position are performing and overseeing others perform activities such as defining needs, product requirements, and associated specifications, making system architecture decisions, outlining design inputs, product design implementation, verification testing, and supporting design validation studies. The ideal candidate is a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The Principal R&D Engineer, Innovation is a subject matter expert (SME) and provides project and engineering leadership in all phases of complex med-device development, as well as ensures compliance to applicable Design Controls policies. The individual may serve as a core or extended team member on PRP/NPD projects. Areas of focus also include systems aspects of identification of user needs, risk assessments as well as product. This position is expected to provide leadership to cross functional teams, and less experienced engineers/technicians.

Job Duties

• 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. Provide critique and design guidance to ensure proper implementation and traceability of design outputs as compared to design inputs.
• 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.

Job Requirements

Required:

• Bachelor’s degree in Electrical, Mechanical, Software or Systems Engineering.
• Minimum years of related experience: 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. Able to balance risk and opportunities.
• 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.

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on:

Competitive salaries, annual bonus and 401(k)* with company match

24/7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance*

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center**

Connected Culture you can embrace:

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position in this location is$131,672.00-$184,342.00/ year, plus potential for annual bonus(subject toplan eligibility andother requirements).

Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes: || United States (US) || Minnesota (US-MN) || Brooklyn Park ||Research and Development