Biomedical Engineer

This individual will have responsibility for working cross-functionally to develop and implement new products through adherence to established design control processes and good engineering and documentation practices.

An ideal candidate would be able to

• Create solutions for technical problems using systematic problem-solving methodologies.
• Manage technical and cross-functional project work by facilitating effective multi-functional communication and engagement;
• Critically evaluate and analyze system performance and reliability and ensure the design space is adequately pressure-tested to satisfy user, regulatory and business requirements.
• 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.
• Drive design assessments and tradeoff decisions at the intersection of material, form factor, process, human factors considerations that enable robust system architecture.
• 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.

Desired Qualifications:

• BS in Mechanical Engineering, Materials Engineering, Biomedical Engineering with mechanical emphasis or related field.
• Minimum of 5 years of post-baccalaureate professional experienceleading or supporting product development projects
• Experience with implementing product changes through a structured, phase-gated product development process
• Extensive experience solving mechanical problems, providing detailed insight and constructive criticism in complex situations, and foreseeing problems along with potential solutions
• 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
• 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
• 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 in light of development efficiency while maintaining a robust design and design standards.
• Deals with ambiguity, making practical assumptions with engineering justification where needed Self-directed with the ability to learn and adapt quickly to multiple and competing requests.
• Comfortable making practical assumptions with engineering justifications, where needed.
• Strong organizational, influencing and coordination skills.
• Demonstrated customer focus, and track record of releasing products.
• Ability to work independently.
• Ability to work under pressure and time constraints.
• Effective interpersonal and collaborative skills.

Job Type: Contract

Pay: $65.00 - $70.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: In person