What are the responsibilities and job description for the Medical Device R&D Engineer position at Spinal Simplicity?
Spinal Simplicity is looking for a Medical Device R&D Engineer works with the Engineering Team to design and develop medical devices that are essential to the Company’s core products and instrumentation, as well as new medical products, devices, and instrumentation from the inception of an idea through production. This position is located in Overland Park, KS.
You Will :
- Work on research, design, development, and engineering of the Company’s core and new medical products, devices and instrumentation. Ensure the execution of timely product design and development.
- Utilize Solidworks and other Company-selected engineering software platforms for engineering projects, document control and project management.
- Apply knowledge of relevant manufacturing processes to apply a design for manufacturability approach.
- Maintain DHF’s, DMR’s, and all other required quality documentation in accordance with applicable law, regulation and Company Quality SOP’s.
- Work with existing and new vendors, manufacturers, and other third parties to achieve engineering and production goals.
- Work on FDA and global regulatory submissions for product clearance (ie., FDA 510K and other submissions; CE Mark; Health Canada).Conduct necessary research, document preparation, and submission work (such as mechanical and other functional product testing).
- Maintain effective communication with all Company team members, including Senior Management and across multi-disciplinary function groups (compliance, sales & marketing, shipping and inventory, customer service).
- Represent the Company with professionalism and integrity at industry conferences, tradeshows, cadaver labs and surgical procedures, educational symposiums, trainings, and workshops.
- Maintain competence and a high level of expertise in the Company’s current and future product portfolio. Establish credibility within the industry as a thought-leader in the spine and orthopedic medical device fields.
- Analyze competitive education and training activities. Stay abreast of product development, regulatory approvals and medical advances of industry leaders and competitors within the Company’s medical disciplines.
- Prioritize and respond to outside inquiries, requests and / or complaints with the appropriate degree of urgency, thoroughness and follow-up.
- Communicate business, product and ethical matters to the appropriate management team members.
- Maintain ongoing compliance with applicable laws and regulations in relation to all work-related duties.
- Perform engineering duties according to applicable quality standards. Work with Company management to meet or exceed accreditation standards.
- Identify and implement "best practices" in all work-related activities.
- Perform other relevant duties, as assigned.
Minimum Requirements :
Physical Requirements :
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions in this job description :
About the Company :
Spinal Simplicity is a company dedicated to the creation of innovative simple solutions for complex spinal problems. With a focus on quality, our products are designed to further enhance patient care while providing physicians with a greater array of minimally invasive devices.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
NOTICE TO THIRD-PARTY AGENCIES :
Spinal Simplicity does not accept unsolicited resumes from recruiters or agencies. Any staffing / employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Spinal Simplicity. Spinal Simplicity will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing / employment agency, person or entity. Staffing / employment agencies who have fee agreements with Spinal Simplicity must submit applicants to Human Resources to be eligible for placement fees.