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Product Development Engineer

2 months ago

Overland Park, United States Spinal Simplicity LLC Full time

Join Spinal Simplicity as the next Product Development Engineer at Spinal Simplicity. The Product Development 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.

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.

You Have:

  • Four-year college degree in mechanical engineering (or relevant engineering field), with preference for a graduate degree.
  • Use computer assisted drafting equipment and software.
  • Ability to comprehend and apply sophisticated logical, critical and scientific thinking on a wide range of intellectually challenging medical and engineering concepts.
  • Excellent Communication skills, verbal and written.
  • Possess requisite knowledge and expertise in the spine and orthopedic products of the Company. Ability to communicate medical product knowledge, as well as clinical knowledge related to spinal and/or relevant orthopedic anatomy, spinal and relevant orthopedic surgical procedures and techniques.
  • Ability to travel overnight on occasion to attend tradeshows, investor meetings, industry training, and/or other work-related activities.
  • Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations.
  • Write protocols, reports, business correspondence, and procedure manuals.
  • Ability to calculate figures relevant to engineering work, along with business related calculations such as discounts, interest, commissions, proportions, percentages, and volume.
  • Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Analytical and problem-solving skills. Able to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to work effectively in a team environment.
  • Have a valid drivers license

Position Location:

This position is located in the corporate in Overland Park, Kansas

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.

www.spinalsimplicity.com

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