About the position
As a key member of the R&D Team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The Product Development Engineer for Hips will manage a specific product or group of products from product definition and planning through production and release. This role involves coordinating employee recruitment, selection and training, performance assessment, work assignments, salary, and recognition/disciplinary actions. You will direct interfaces with central resources in design, process, manufacturing, test, quality, and marketing as the product(s) move to completion and distribution. Additionally, you will manage production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; redesign of devices; analysis of customer returns; and optimization of device production relative to cost constraints. You will also serve as an adviser to the sales force and customers on all matters concerned with designated products, recommending product program development and/or enhancements based on feedback.
Responsibilities
- Responsible for 2D and 3D drawings, including stack analysis, aimed at the implementation of prototypes, implantable devices, instruments for Base Business devices, instrument trays and instrument sets.
- Design and technical management of custom cases with the support of the Product Development team.
- Develop and manage needed documentation for the development and registration of Custom implantable components and instruments.
- Evaluation and responsibility of congruency of design Inputs.
- Actively discuss case design with surgeons and sales reps, critically evaluating components design inputs.
- Provide surgical field support for custom made products.
- Proactively communicate within Company Functions for the respect of designed products timelines, costs and quality standard.
- Evaluate possible design flow implementation.
- Participate at meetings with KOL/internal and external stakeholders to collect Base Business project requirements.
- Analyze Base Business project requirements and translate them into project inputs, validation, and verification requirements (IOVV).
- Ensure the feasibility of the design and interact with manufacturing to transform prototypes into production.
- Define technical specifications, work instructions, standard operating procedures (SOP), test plans, testing protocols, and verification protocols for instruments sets.
- Create the required technical documentation for certification renewals and geographical expansion.
Requirements
- Bachelor’s degree from an accredited college in a related discipline, or equivalent experience/combined education, with 2 years of professional experience; or no experience required with a related Masters degree.
- Medical Device industry experience required.
- Effective communication skills.
- Demonstrated mastery of 2D and 3D drawing.
- Knowledgeable of mechanical design and materials for orthopedic use.
- Demonstrated knowledge of NX and technical engineering (HMI, basics).
- Ability to adopt a can-do approach in areas of functional, ethical, and compliant behavior.
- Ability to work cross-functionally and make complex decisions.
- Understanding of medical language, procedures, technology, and science.
- Advanced skills in precision, detail-oriented and methodological FEM analysis.
Nice-to-haves
- Interpersonal skills.
- Exhibits attributes in passion, collaboration, partnership, rigor, transparency, and communication.
- Segmentation systems knowledge.
- Technical support in the OR.
- Knowledge and understanding of the applicable laws and regulations for the medical industry.
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Spending and Savings Accounts
- 401(k) Plan
- Vacation, Sick Leave, and Holidays
- Income Protection Plans
- Discounted Insurance Rates
- Legal Services
