Senior R&D Engineer

Working Location: Minnesota, Minneapolis 

Workplace Flexibility: Hybrid

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

 

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

 

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

 

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Sr. Engineer will support, or lead, various efforts associated with OSTA’s product development activities under the guidance of an R&D Core Team member or R&D Manager.  

Under the direction of an R&D Core Team Leader, or R&D Manager, the Sr. Engineer will support, and/or lead, engineering efforts throughout OSTA’s PDP+ stage-gate development process, including: design ideation and evaluation of concepts and technologies, prototyping and feasibility testing, development and/or management of design inputs, developing product specifications and drawings, planning and conducting design evaluation studies / tests, and developing and/or executing design verification and validation testing.  

Within a dynamic and collaborative team environment, the Sr. Engineering will proactively manage their tasks / projects, ensure their deliverables are high quality, consistently seeks to advance their knowledge and skills, and ensure compliance to all applicable SOP’s and regulations.  Creation of technical data, data analysis, and subsequent reporting will be an important aspect of this role, as well as helping to generate all documents / deliverables that will comprise the Design History File; therefore, a working knowledge of FDA Design Controls is required.

Job Duties

• Supports the technical efforts of the Core Team (or Manager) on product development and/or technology development efforts.
• Contributes to product development activities and deliverables, such as; product requirements creation/documentation, ideation & prototyping, drawings and specifications, technical risk mitigation, design evaluation testing & studies, test method development, data analysis, verification and validation testing and reports, design reviews, etc.
• Develops product verification and validation testing strategies with a broad view of all inputs, authors testing protocols and reports, and supports testing as required. 
• Develops engineering solutions in partnership with R&D team to ensure alignment with product and project requirements (e.g,. cost, quality, delivery, etc.).
• Routinely updates R&D manager through weekly discussions and monthly updates.  Capable of prioritizing and organizing work/efforts based on project priorities.
• Ensures all deliverables are completed with a high degree of quality, attention to detail, and on time.
• Applies statistics to their work, when applicable based on risk analysis efforts, to ensure product quality.
• Collaborates / communicates, and documents detailed product development strategies while mindful of the interests of all Core Team Members.
• Lead product development resources, and extended team members, through a product development stage gate process from concept to launch.
• Develops, or oversees the development of, User and Product Requirements and resulting Verification and Validation efforts to ensure the product effectively meets its requirements.
• Proactively ideates additional opportunities to reduce technical risk and implement contingency planning.
• Gains a thorough understanding of the procedure, products use, and environmental factors to ensure appropriate design decisions.
• Supports suppliers involved in product development and ongoing production; including external design and development partners.
• Documents innovations in partnership with Olympus Patent Attorneys 
• Proactively supports the all efforts with a positive and results-oriented attitude.

Job Qualifiations

Required:

• Bachelor’s degree in mechanical engineering or similar.
• Minimum of 5 years or related experience, or Minimum of 4 years with MS or minimum of 3 with PhD.
• Skills/Competencies/Other considerations:
• Experience in Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process.  

 

Preferred:

• Working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.). 
• Capable of developing many of the deliverables required to document the product desi