Sr Staff Engr, Product Development - Kaygen Inc.

KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries

Description:

• This individual will have responsibility for working cross-functionally to understand end-user needs, translating those into system requirements and mapping them to design specifications, and developing an efficient architecture, ensuring a detailed and well-tested design.
• An ideal candidate would be able to manage technical and cross-functional project work that may include all phases of product development, including defining, clarifying, and documenting requirements; performing the necessary design analysis and trade-offs; designing the disposable layout and defining sub-components, recognizing when interface impacts might occur and taking early action to avoid problems; ensuring robust test method development, design verification and design validation plans and overseeing the execution; and supporting design transfer activities.

Additionally, this individual may coach and mentor other associates. Responsibilities include but are not limited to the following.

• Drive R&D activities over the continuum of product development; Define, plan, coordinate, and execute R&D deliverables on the program and maintain collaborative relationships with a cross-functional team including Marketing, Quality, Regulatory, Manufacturing Technology, and Operations.
• Lead project workstreams or projects cross-functionally.
• Translate customer and operational requirements into verifiable product requirements and specifications for product systems, subsystems, interfaces, and components and maintain traceability throughout the development process.
• Drive design decisions at the intersection of material, form factor, process, and human factors considerations that enable robust system architectures that are built upon deep subject matter expertise in key foundational technology domains.
• Synthesize, develop, update, and optimize designs that meet requirements by understanding design space with design options and trade-offs, managing critical parameters, leveraging strong engineering fundamentals and tools, and integrating manufacturing principles early in development.
• Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory, and business requirements. Understand system and subsystem design sensitivity and identify and address early any potential design integration and transfer risks.
• Implement DFSS rigor throughout the design selection and development process, leveraging and deploying empirical, statistical, and analytical tools that will improve design decisions and reduce design iteration cycle times.
• Ensure the design considerations embed all applicable DFX (Design for Excellence) aspects including manufacturability, usability, reliability, and safety.
• Provide technical leadership for product design aspects for developmental and commercial products within the platforms throughout their entire lifecycle.
• Resolve technical problems.
• Create solutions for technical problems using systematic problem-solving methodologies.
• Provide subject matter expertise and stay current with cutting-edge technologies and material advancements to improve the rigor of Design and Development.
• Conduct in-depth research and assessment of the industry landscape from IP, regulatory, products, and technologies standpoints.
• Present and lead technical reviews at the various stages of Design and development.
• Facilitate effective multi-functional communication and engagement.
• Mentor junior engineers and technicians in the execution of R&D project deliverables.
• Follow the Design Control process for medical devices and ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.

Minimum Qualifications:

• Bachelors degree in mechanical engineering, Materials Engineering, or Biomedical Engineering with mechanical emphasis or related field.
• Minimum of 8 years of post-baccalaureate professional experience leading or supporting product development projects.
• Experience with implementing product changes through a structured, phase-gated product development process.
• Extensive experience solving problems, providing detailed insight and constructive criticism in complex situations, and foreseeing problems along with potential solutions.
• Ability to appropriately set a technical strategy, distill the vision into an actionable plan and delegate effectively to extended engineering team members.
• Strong leadership and team-building skills. Demonstrated ability to drive stakeholder alignment and collaboration.
• Supervisory experience managing engineering teams and developing the capability of engineers.

Desired Qualifications:

• Graduate degree (MS or PhD) in Mechanical Engineering, Biomedical Engineering, or related field.
• 10+ years of post-educational experience in Medical Device development.
• Experience with design best practices, including advanced tolerance design, and design for reliability. Design for Six Sigma, Design for Manufacturability training/experience
• Experience with injection molded plastics and the design of high-volume disposables.
• Experience as a lead in the development of medical disposable devices.
• Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
• Expertise in common risk management techniques.
• Experience in modeling, simulations, and sensitivity analyses.
• Experience in development using cross-functional teams ideally in a healthcare, medical technology, or life sciences area.
• Demonstrated ability to work well in matrix organizational structure.
• Working knowledge of regulatory standards applicable to the design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971, and IEC 60601 and collateral standards

Competencies:

• Excellent written & verbal communication skills.
• Ability to challenge the status quo considering development efficiency while maintaining robust design and design standards.
• Self-directed with the ability to learn and adapt quickly to multiple and competing requests.
• Strong organizational, influencing, and coordination skills.
• Demonstrated customer focus, and track record of releasing products.
• Must be comfortable making practical assumptions with engineering justifications, where needed.
• Ability to work independently.
• Ability to work under pressure and time constraints.
• Effective interpersonal and collaborative skills.
• Deals with ambiguity, making practical assumptions with engineering justification where needed.
• Masters the technical skills, knowledge, and tasks associated.

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at www.kaygen.com.

Benefits:

• Healthcare Insurance
• Vision and Dental Insurance
• 401(k) Retirement Plan
• Free Life Insurance
• Vacation Time Off
• Sick Time Off
• Family Medical Leave (FMLA)

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