Direct Hire – Minneapolis, MN
Heraeus Medical Components is a world leader in development and manufacturing of components and finished devices for the medical device industry. They combine unmatched expertise in material science, engineering know-how, design, global outsourcing and state-of-the-art precision manufacturing to deliver a wide-ranging portfolio of components, finished devices and solutions for the world’s leading medical device companies. These innovations not only help customers to meet the needs of today’s demanding and competitive healthcare marketplace, they also make a significant impact in the quality of care.
This position will be engaged in design and product development of finished medical products and will have engineering responsibilities for the development of new finished medical products and medical assemblies. This position will be instrumental in guiding the development of the key prototype processes for Design For Manufacturability concepts. Activity will be varied including some hands-on, customer interface, and many strategic technical elements.
- Support Design and Development Projects for Medical Products and Processes..
- Execute deliverables for Design Control process to deliver the desired product to production in a cost effective manner while hitting product performance and profitability goals; project responsibilities will include support in production until product meets intended profitability and quality targets.
- Demonstrate and utilize tried and true Engineering methods and resources to streamline the development process.
- Use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE).
- Partner with manufacturing and quality engineering, business development and production management to establish, implement and deliver products to production that meet their design and profitability targets within the first 3 months of release to production.
- Facilitate the completion of the necessary activities required by the MDD and ISO/EN standards and Design Control / Process Validation within the requirements of our procedures.
- Communicate pertinent information to management and to customers.
- Assist in the development of in-process quality manufacturing practices to support development projects.
- Ensure technical accomplishments and other testing is fully documented for reference and traceability.
- Adherence to Code of Conduct as applicable to the role
- Develop and monitor quarterly goals.
- Provide periodic updates on progress of projects.
- Product Development (R&D) Engineering experience in ISO 13485 regulated environment and demonstrated competence
- Knowledge and experience with ISO 13485:2003 Design Control and Process Validation documentation
- Knowledge of and effective application of engineering tools (e.g., DOE, SPC, Process Validation)
- Knowledge of clinical applications for interventional medical procedures required
- Knowledge of Development for Lean Manufacturing experience a plus
- Skills and experience in developing medical devices for invasive procedures. Knowledge of Guidewire and Catheter manufacturing processes a plus such as centerless or OD wire grinding, coil winding, solder, hydrophilic coatings, plastic reflow, and catheter assembly techniques.
- Highly effective communication and technical writing skills. Demonstrated computer literacy and competency.
- Demonstrated skills in successfully working with customers. Collaboration with customer representatives on the team will be important
- Solve complex engineering problems through the effective use of available resources, colleagues, and 3rd parties.
- Prototypes and design for manufacturability
- B.S. in Engineering or Related Technical Field strongly preferred
- 2+ years’ Engineering Experience preferred (Finished Device experience a plus)
- A person of integrity that makes commitments thoughtfully and seriously. This person will do whatever is reasonable to deliver excellence on those commitments.
- Practical and “as simple as possible” approach to Engineering and a partnering style with colleagues in all functions in the business
- Optimistic approach to challenges – “can do” style
- Highly communicative, thorough and concise