Job Description

The Principal Engineer is responsible for performing and/or leading all aspects of product development including: technical planning and development strategy development, development of design inputs, supporting development/design execution, and directing/supporting verification and validation efforts. It will be the responsibility of the Principal Engineer to ensure well defined product and performance specifications for the system are defined and mapped to applicable and appropriate test cases and ensure all efforts are completed on schedule, while proactively mitigating potential issues, to enable the timely launch of high quality / reliable products. He or she must fully understand medical device design control requirements and be able to provide effective technical leadership to product development efforts and team members, negotiate strategies with cross-functional leaders, and work collaboratively across the organization. The Principal Engineer will serve as a core or extended team member on development projects. As the Principal Engineer will heavily contribute to Design History Files, maintaining detailed documentation throughout all phases of research and development is essential.

Job Duties

• Provides technical leadership on product development projects and/or technology development efforts.
• Accountable for all aspects of product development activities and associated Design History Files, such as; requirements creation and documentation, product ideation & prototyping, design & development documentation, risk management documentation, verification testing strategy and reports, design validation studies, design reviews, electronic change orders, as well as support for regulatory submissions.
• Capable of leading & developing all Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality.
• Develops engineering solutions and innovations, collaborates with Olympus IP Attorneys as needed.
• Ideates, evaluates, and directs team towards preferred design options which will meet product/performance requirements, cost targets, and manufacturability requirements.
• Maintains a deep understanding of applicable industry guidance documents and testing standards and ensures appropriate consideration and compliance. Accountable for collaborations with external safety testing and certification efforts where applicable.
• Directs or performs design analysis, such as power budgets, safety margin, memory allocation and MTBF.
• Partners with the software developers to ensure electrical design works seamlessly within the software architecture, identifies potential issues, and negotiates trade-offs as required.
• Accountable for the development of effective/efficient product verification and validation testing strategies, testing protocols and reports, and ensures products meets/exceed established specifications.
• Ensures user requirements are thoroughly traced to test cases where applicable.
• Employs statistical techniques to establish exceptional product quality, reliability, and robustness.
• Consults with the Sales, Marketing, and clinicians to define and specify product user requirements and ensures product and performance specifications are appropriate and accurate.
• Manages / directs internal and external design partners, suppliers and manufacturers as needed.
• Leads / plans testing to support marketing collateral, training programs, and launch activities.
• Provides regular updates to engineering and marketing leadership on product status and advancement.
• Supports engineering leadership as required.
• All additional duties as directed.

Job Qualifications

Required:

• Bachelor’s degree in Engineering (Electrical or Biomedical / Mechanical with electrical experience preferred)
• Minimum years of related experience: 9+ years or 8+ years with MS or 5+ with PhD
• Extensive working knowledge of, and experience in applying, FDA Design Controls and international standards (e.g., Design Controls, 820-CFR, ISO14971, ISO10993, IEC60601, GMP, etc.).
• Knowledge of printed circuit board design and manufacturing processes. Experienced in developing schematics, selection of components, and current knowledge of developments in the electronics industry.
• Working knowledge of printed circuit board design tools (e.g., Altium or OrCAD) and capability to evaluate and scrutinize designs and Gerber data.
• Capable of identifying design / performance issues or concerns early in a program and proactively implementing contingency plans and/or planning for mitigations (e.g., electromagnetic compatibility).
• Ability to effectively work within a requirements management system, such as Doors, JAMA, etc. and perform hardware risk analyses and hardware DFMEAs.
• Ability to effectively work within a requirements management system (e.g., JAMA, Doors) and ensure all requirements are appropriately translated into concise / articulate requirements and mapped to test cases.
• Experienced in hardware risk management efforts; Risk Analyses, DFMEA’s, etc.

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.
• Capable of leading & developing all Design Control deliverables required to document a product design and establish compliance with Design Inputs with appropriate specificity and quality.
• Proficient in Microsoft Windows Office applications including MS Outlook, MS Powerpoint, MS Project, Visio, etc..
• Knowledge of common manufacturing methodologies, technologies, and materials employed in medical devices.
• Experienced in solving challenging and/or ambiguous engineering problems with scientific logic and problem solving skills. Ability to communicate complex technical concepts clearly and concisely.
• Experienced in applying good judgement and making timely decisions while considerate of technical/business risks in a variety of situations.
• 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 be able to work in a professional open-space environment without distracting others.
• Must have a positive attitude and capable of motivating teams / team members to accomplish efforts in a timely manner and with high quality.

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