R&D Design and Development Engineer – Implantable Medical Devices
Job Description: As a Design & Development Engineer, you design and develop various Class II and Class III medical devices. We are searching for engineers with "hands on" experience in both design and development. We seek engineers who are career-driven, have strong analytical and technical skills and a depth of experience in front end design.
Job Details:
Salary and Title – Commensurate with Experience, Skill Sets of the individual, and Location
Reports to: Executive Director of R&D
Competitive Benefits
Job Type – Full time
Job Location - Continental United States (prefer Minneapolis or the Southeast but can work remotely) Remote position will require travel to HQ and other locations. Travel required is approximately 35% and can vary depending on level and type of activity at any point in time.
Education Requirement:
Bachelor's degree in mechanical engineering, biomedical engineering, biotech, or equivalent. Advanced degree preferred.
Company Background:
We are a medical device accelerator focused on early-stage implantable medical devices which are highly differentiated and provide unique clinical and economic benefits to patients and payers respectively. We are funded entirely by high net-worth individuals, not venture capitalists. Once a project is approved, the funding continues to ensure successful commercialization of the technology. Today there are two medical devices the company is focused on developing. The goal is to have a minimum of two to three products in development at any point in time.
Position Responsibilities:
- Engineering analysis, pre-clinical studies support, clinical studies support, and documentation all within our design controls system.
- You are skilled in force, stress, strain, tolerance, materials, process capability, and industry standards analysis.
- Documentation including essential standard elements such as engineering drawings, engineering characterization reports, assembly procedures, flowcharts, test plans, and test reports.
- Design verification and validation protocols and reports, working with outside vendors to coordinate validation activities.
- Plan and schedule activities necessary to meet timelines.
- Design and coordinate the execution of engineering experiments and formal verification tests.
- Design, procure and / or fabricate the tooling and fixtures needed for your research and development.
- Perform troubleshooting on problems with new products as related to design, material, or process.
- Analyze, summarize, and draw conclusions from your test results. Through complete and accurate reports, you share your results with the technical team and other stakeholders.
- Work cooperatively with all functional areas e.g. manufacturing, process development, quality, regulatory, and clinical entities to ensure project success.
Position Qualifications:
- Experience in leading key project/product development activities
- Experience creating protocols and authoring reports.
- A track record of accomplishment in design and testing of Class II or Class III devices
- Documentation including essential standard elements such as engineering drawings, engineering characterization reports, assembly procedures, flowcharts, test plans, and test reports.
- Design verification and validation protocols and reports, working with outside vendors to coordinate validation activities.
- Design Control experience including full product development, from concept to manufacturing transfer is required
- Demonstrated project / program management experience with implantable medical device R&D and / or manufacturing working with internal and external customers
- Strong competencies in planning, project management, and organization with the ability to lead multiple activities and resources while maintaining a focus on quality
- The ability to solve technical problems, implementing practical solutions based on device requirements and project timelines
- Excellent communications skills; oral, written, and electronic
- Excellent statistical and analytical skills
- Working knowledge of FDA Quality regulations related to implantable medical devices
- Experience writing manufacturing procedures.
- Risk analysis experience
- Vendor contract experience
- SolidWorks design and PDM experience
- Design history file (DHF) knowledge
- Polymer knowledge
- A track record of accomplishment in design and testing of Class II or Class III devices
- Project ownership of significant size and scope
- The ability to solve technical problems, implementing practical solutions based on device requirements and project timelines
- Excellent communications skills; oral, written and electronic
- Excellent statistical and analytical skills
- Demonstrated ability to design for manufacturability and implementing quality standards
- Experience working on DFMEA and PFMEA activities for new medical device products to improve design and process performances
- Experienced with Geometric Dimensioning and Tolerancing, Design Control, Design and Process Validations, Gauge R&R, Test Method validations, pilot manufacturing for clinical builds, design transfer for commercial manufacturing
- Experience working with Design History files from prototype to market release for medical devices.
- Experience optimizing processes, developing and implementing test procedures, forming process parameters, test methods and standard operating procedures, capacity and profitability for medical device manufacturing
- Proficiency with MS Project and Microsoft Office Suite
Benefits:
Medical, dental and vision coverage
401(k) program
Paid holiday schedule and vacation accrual
Disability and Life Insurance
Equal Opportunity Statement: The company is an Equal Opportunity Employer and Prohibits Discrimination or Harassment of Any Kind: We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination or harassment. We want you to succeed.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
COVID-19 considerations:
Vaccination requirements
Application Question(s):
- Do you have experience working on DFMEA & PFMEA activities for new medical device products to improve design and process performances?
- Do you have Polymer Knowledge and a track record of accomplishment in design and testing of Class II or Class III Devices.
Education:
Experience:
- program mgmt. exp. w/ implantable medical devices: 4 years (Preferred)
Work Location: Multiple Locations