FLSA Status: Non-Exempt
Department Name: Engineering
Supervisors Title: Engineering Manager
Primary Purpose and Function
The Senior Product Development Engineer performs product design activities and coordinates production of prototypes for Product Development. The Senior Product Development Engineer will also be responsible for design and development of products from initial concept through market release with little to no supervision, adhering to established company policies/procedures as well as applicable FDA/ISO regulations.
Essential Functions and Responsibilities
- Consults with the marketing staff, consulting surgeons, and manufacturing contractors, as required, to facilitate proper design or production.
- Acts as a subject matter expert on the design of special products.
- Prepares/reviews design drawings and acts as an advisor in the preparation of final drawings.
- Coordinates and provides technical assistance in the production of prototypes.
- Performs First Article Inspections (FAI) as needed.
- Provides technical expertise for manufacturing as directed.
- Travels, as required, for professional meetings or in association with product development or technical activities, which includes providing technical surgeon advice and key participant in surgeon design meetings
- Leads or co-leads product development and teams.
- Works with outside legal consultants, and Government Patent Officials, as required, on patent searches, patent infringements, and patent applications and acts as technical expert on all design related materials and provides strategic analysis for continued direction.
- Develops technical documents, training programs, and technical presentations for customers and/or the sales force.
- Provides surgeons training through technical presentations, and saw bone demonstrations.
- Practice integrity, reliability and honesty in all business transactions
- Project a positive company image at all times
- Work with co-workers as a team to ensure success
- Other duties as assigned by the Engineering Manager or designee.
Knowledge and Skill
- Ability to demonstrate strong analytical and problem solving skills
- Competent in MS Office products and efficient in email and internet applications
- Proficient in Solidworks & Solidworks PDM applications
- High accuracy in work and attention to detail
- Bachelor’s degree required from an accredited institution or equivalent
- 5-7 years’ experience in spine/orthopedic related field.
- In-depth knowledge of FDA 21 CFR Parts 801, 803, 806, 820 and 822 as well as ISO 13485 & 14971
- Sitting for long periods of time
- Travel up to 30%
- Frequent standing for pro-longed times
- Oral communication over the phone and in person
- Occasional lifting of 20+ lbs.
Company Policy/Procedural Compliance
Follow all company policies and procedures as well as local, state and federal laws concerning employment to include, but not limited to: I-9 information, EEOC, Civil Rights and ADA.
Please email resume and cover letter to firstname.lastname@example.org.