Job Description

The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development efforts within the Olympus Surgical Technologies of America (OSTA) organization. The ideal candidate will be a hands-on project and multi-disciplinary technical leader with a strong systems design and integration background. The candidate will be looked upon as a subject matter expert (SME), and will provide project and engineering leadership in all phases of device development, as well as ensure compliance to applicable Design Controls, Product Security, and Cybersecurity policies. Areas of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, product security, cybersecurity, and equipment development oversight.

Extensive knowledge of medical device design control requirements, system design and software and hardware integration and testing, and design for manufacturability and testability is required. Deep understanding of medical device standards, and experience in their application, is required. This position is expected to provide leadership/mentorship to cross functional teams, and less experienced engineers/technicians.

Job Duties

• Provide project and technical leadership 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 Marketing in collection of user needs/feedback on product requirements and concepts
• Lead the requirements development and management process, incorporating risk management elements as required.
• Ensure compliance to product security and cyber security policies, and support efforts to author local SOP’s to ensure compliance.
• 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 IPLegal 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 statistically sound design verification protocols/reports, design validation, and delivery system qualification activities
• Lead the system safety certification process to standards such as EN60601-1, EN60601-1-2. Ensure software is developed in compliance to the methodologies of EN 62304.
• 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 Qualifications

Required:

• Bachelor’s degree in Engineering or the equivalent in years of industry experience.
• Minimum years of related experience: 9 years with BS, 8 years with MS, or 5 years with PhD
• Must have extensive working knowledge of, and experience in applying / developing, products in compliance with FDA and international requirements, including 820-CFR, ISO14971, IEC60601, GMP and other standards as they relate to the development and manufacture of medical devices.
• Capable of developing all deliverables required to document the product design with appropriate specificity to enable high volume manufacturing with high quality.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS PowerPoint, MS Project, Visio, etc..
• Solidworks working knowledge. Proficient in the creation and critical review of engineering drawings, tolerancing and tolerance analysis.
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Ability and experienced in approaching challenging and/or ambiguous engineering problems with scientific logic and problem solving skills. Ability to communicate complex technical concepts clearly and concisely is required.

Preferred:

• Established track record of leading Medical Device development and/or sustaining engineering efforts utilizing a stage-gate process. Experience in hand held electro-mechanical devices is preferred.
• Experience applying good judgement to make timely decisions as well as exhibit the ability to balance risk vs. benefits in a variety of situations.
• Ability to effectively work within a requirements management system (e.g., JAMA, Doors) preferred.
• Experience in the practical application of statistics and working knowledge of a statistical analysis package (Minitab).
• Must be able to collaborate effectively with others, work well within cross-functional teams and across multiple sites, as applicable. Must be capable of effectively directing project teams on multiple work streams in parallel and leading teams towards accomplishment of objectives. Must be able to communicate effectively at all levels, both verbally and in writing. Strong presentation skills and the ability influence. Must have a positive attitude and capable of motivating teams / team members to accomplish efforts in a timely manner and with high quality.