Mechanical Engineer - REF126R

  • Full-time

Company Description

ABOUT spencer®

Spencer Health Solutions (www.spencerhealthsolutions.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists, and family members digitally.

The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada, and Europe.

Job Description

The Mechanical Engineer will be responsible for design, development, verification, validation and project leadership activities across the spencer platform.  This will include a focus on production continuity and scale, cost reduction, reliability, product line extensions, process improvement and customer / patient experience.  The individual will ensure excellence in technical investigations, design practices, process qualifications and design / process documentation.   All activities will be performed in accordance with regulated Design Control systems utilizing effective project management tools.  The individual will excel at project alignment, inter-departmental collaboration and personal accountability and they will serve as a beacon of excellence in change management, project planning, and continuous process improvement.

 

RESPONSIBILITIES

  • Drive customer complaints and device failure investigations to root cause
  • Lead and execute Reliability design and process projects
  • Execute projects related to production or service qualification, scale and yield improvements
  • Work with suppliers for alternate supplier/component/ tooling qualifications
  • Develop test protocols and execute extensive reliability/validation tests
  • Update documents and procedures as required and in accordance with NPI/CR processes
  • Execute projects related to Product Life-Cycle Management and Pharmacy Operations
  • Toggle between individual technical contributor, project manager, and team leader
  • Drafting and modeling of hardware components.
  • Work closely with other mechanical engineers to define new products and ensure products meet or exceed customer requirements.
  • Performs hardware qualification testing of POC’s.
  • Analyze designs, perform testing, and do feasibility studies of subsystems, assemblies, and their components to identify opportunities for design, cost, or time-to-market improvements.
  • Qualifies vendors as per Spencer’s specifications.
  • Leads team in process improvement activities.
  • Creates manufacturing instructions and specifications.
  • Ensures all hardware design activities are accomplished within Spencer’s Quality Management System.

Qualifications

  • Bachelor’s degree in mechanical engineering
  • 6+ years’ experience in design and development of commercial or consumer products
  • Experience in drafting and modeling in parametric CAD software tools; SolidWorks preferred
  • Experience in Prototyping & Mockups with Plastics. (Injection Molding)
  • Proficient knowledge of hardware qualification testing of POC’s.
  • Exceptional interpersonal skills and innovative problem solving skills.
  • Experience working in a regulated environment
  • Ability to read, understand, and execute job functions in accordance with  Standard Operating Procedures

Additional Information

Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.

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