Job Title: Engineer - R&D Engineer III
Location: Maple Grove, MN 55311
Duration: 9+ Months
Job Description:
Purpose Statement
- This role is for an innovative technical leader to support BSC’s Peripheral Interventions (PI) Division within R&D. Responsible for developing new technologies, products, materials, processes, or equipment with minimal supervision.
- Independently, or as a member of a team, develops, directs, and executes plans for major segments of complex projects.
- Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
- Responsibilities may include supporting existing products and/or developing new products within a cross-functional environment.
Key Responsibilities:
- Coordinates manages, and documents project goals and progress of an R&D team and recommends appropriate actions.
- Assesses the feasibility and soundness of proposed products, engineering evaluation tests, and equipment.
- Translates customer needs into product requirements and design specifications.
- Responsible for engineering documentation.
- Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
- Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes, or equipment.
- Successfully completes complex engineering work in one or more of the following
- technology development, product design and development, testing of materials or products, preparation of specifications, process study, research investigation, and report preparation.
- Select techniques to solve complex problems and make sound design recommendations.
- Summarizes, analyzes, and draws conclusions from complex test results.
- Designs and prepares complex reports to communicate results to the technical community.
- Designs and coordinates complex engineering tests and experiments.
- Makes data-driven decisions to guide project direction and success
- Maintains a high level of organization to ensure smooth project information & task flow
- Understands the interconnectivity of project workstreams, components, and subsystems to ensure that communication flows smoothly between different workstreams
- Prioritizes documentation to support information sharing and quality control
- Demonstrates knowledge of design controls within the BSC quality system
- Works collaboratively with the team and actively contributes to our positive work culture
Qualifications:
- Minimum of 5 Years with BS, or 3 - 6 Years with MS, or 1 - 3 Years with PhD
- Mechanical or Biomedical Engineering degree or equivalent required
- Work mode: onsite
- Quality system and design control integration experience
- Strong ability to interact and collaborate with doctors in the field, preclinical studies, and in the lab
- Effective communication skills required to coordinate between cross-functional work streams within a project
- Flexible engineer capable of adapting to varying project demands while remaining focused on the work at hand
Preferred Qualifications:
- Biomedical or anatomy experience and/or aptitude
- Medical device quality system knowledge
- Medical device product development system knowledge (PDP/TDP)
- Full PDP process experience on Class II or Class III devices
- Technical Project Management experience
Thrombectomy experience:
- Setting up design controls on prints for the peening method and low pressure tester - test method development
- Finishing Liner Annealing study – test planning/execution/analysis
- Support Design Controls – specs and risk documentation
- Support DV testing – test planning/execution/analysis/SOP alignment
- Support EDO Limit Challenge – test planning/execution/analysis/SOP alignment
Quality System Requirements
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Job Type: Contract
Pay: $55.00 - $58.00 per hour
Schedule:
Work Location: On the road