I: Job Summary

The Device Engineer will support product development and verification testing activities for a wide variety of medical device combination product projects including auto-injectors and nasal spray devices. Candidate should have a strong engineering, analysis, and statistics foundation. Candidate should be experienced with good laboratory practices, drafting of protocols and test procedures, test execution, report writing. Knowledge of R&D test qualification processes is expected. Knowledge of FDA/ISO device quality system requirements is expected.

They will contribute to the successful execution of engineering activities involved in conceptualization, feasibility, design, development, testing, transfer to manufacturing and launch of new products. Candidate is expected to be comfortable in a lab setting - preparing, designing, and performing various tests. Experience with fabrication equipment is desired.

They may lead medical device engineering activities and may serve as device technical lead on one or more projects. They execute their own work and also oversee the engineering work of multiple contractors including design firms, laboratories, and manufacturing organizations.

II: Essential Functions

TECHNICAL:

• Develop drug-delivery devices
  • Analyze, design, and develop solutions to engineering challenges associated with complex mechanical and fluidic assemblies
  • Create & review 3D models, engineering drawings, specifications, tolerance analyses, DFM/DFA, and other design collateral
  • Develop and execute test plans for development, verification, and validation of designs
  • In collaboration with manufacturing teammates, develops fabrication and assembly processes for new products and ensures Design for Manufacturability.
  • Collaborate with Manufacturing Engineering on the design and selection of tooling and production equipment for successful transfer of new products to manufacturing.
  • Develop intellectual property through invention disclosures and patent writing
  • Analyze standards (ISO, ASTM, USP, etc.) and guidance documents (FDA, ICH, etc.)
  • Perform risk analyses for drug-delivery devices, in accordance with ISO 14971.
  • Document results in reports such as dFMEA, pFMEA, FTA, Risk Management Report
• Assist and lend expertise in engineering problem solving activities related to existing products.
• Author, review and approve various technical documents and support Design History File creation and maintenance
• Oversee evaluation of changes (component, product, process) pre-design transfer.

LEADERSHIP:

• Self-motivated and able to use good judgement, prioritize and work with minimal supervision.
• Develop, deliver, and execute well-formulated plans and schedules for all assigned work
• Regularly provide clear communication and documentation on progress, challenges and outcomes.
• Collaborate with colleagues on an integrated team to provide medical device subject matter expertise to create and advance products from concept to commercialization
• Prepare risk mitigation plans and cost-effective strategies to ensure delivery of new products within time, cost, and quality constraints.
• Collaborate with device design firms & manufacturers in the development of delivery devices
• Collaborate with contract research laboratories and internal team to execute device performance testing
• Lead engineering Design Reviews & Technical Reviews as appropriate
• Able to communicate clearly and concisely. Strong writer. Comfortable presenting information to team members and other stakeholders.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

Candidate must possess:

• A minimum of a Bachelor's or advanced degree in Mechanical Engineering (or a related engineering discipline). Masters degree preferred.
• 3+ years of experience in medical device design and development, process development or lab testing in a regulated environment (med device, pharma, biotech)
• Experience with combination product/drug delivery devices including auto-injectors, injection pens, reconstitution and dissolution devices, patch/pumps, pre-filled syringes, nasal spray devices, inhalers or other novel delivery technologies is highly preferred
• Experience with part and assembly design utilizing injection molding and associated tooling, materials, and machinery
• Knowledge of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products
• Proficiency with 3D computer-aided design (SolidWorks preferred)
• Experience with Design of Experiments (DOE), statistical analysis and statistical analysis software (e.g. Minitab) is preferred
• Able to travel domestic / internationally (up to 25%)