Staff Research Development Engineer

Must haves:

1:Experience with test method development

2.Capital development

3. Ex vivo testing (Testing tissues or animal parts - not on live animals)

4. Ablation technology is a big plus

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 tradeoffs; 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 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 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, 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 tradeoffs, managing critical parameters, leverage strong engineering fundamentals and tools and integrating manufacturing principles early in the 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 which will improve design decisions and reduce design iteration cycle times.

Ensure the design considerations are embedding 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, technologies standpoint. 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:

Bachelor's degree in Mechanical Engineering, Materials Engineering, 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 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 design of high-volume disposables.

Experience as 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 design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards