Senior Engineer, New Product Development
The Senior Engineer will be responsible for the product design and development aspects of a complex project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This position is expected to develop an expert knowledge of products and will assist in providing product support to the field as required. This is accomplished by maintaining Tecomet’s principles of Safety, Quality, Customer Satisfaction and Innovations.
- Lead cross functional project teams through all phases of the product development process including planning and product launch.
- Lead all aspects of the project management functions including scope definition, budgeting, and contingency planning.
- Work closely with project core team (marketing, manufacturing, quality, testing etc) and surgeons to define user needs, generate design concepts and prototypes, and perform design evaluations (such as tolerance analysis, FEA, DOE, simulated use testing etc).
- Support development of product process validation plans and testing.
- Collaborate with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Medical device industry
- Project Management
- Three-Dimensional Parametric Solid Modeling
- FDA QSR and ISO13485quality standards
- Quality standards within the company
- Schedulingwork to achieve goals
- Customer focused environment
- Business systems and knowledge of impact to business
- Strong organizational skills
- Strong people and leadership skills
- Excellent verbal, written and presentation skills required.
- Problem solving and evaluation
- Process improvements
- Computer operation; Proficiency in MS Office Suite
- Project management
- Streamlining processes
- Self Motivated
- Speak in front of people in a variety of settings
- Be flexible and adapt to changes in the market place
- Interface professionally and courteously with customers/public/internal staff
- Prioritize work
- Meet goals and objectives set for department and company
- Keep current in changing work methods and regulatory changes
EDUCATION AND WORK EXPERIENCE
- A minimum of a BA/BS in Engineering plus 6years of experience or an MSdegree in Engineering plus 4years of experience is required. Advanced degree is preferred. A degree in Biomedical Engineering or Mechanical Engineering would be preferred.
- Experience with medical device development is strongly preferred. Previous experience in new product development is required.
- Must have experience in identifying user needs, device design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required.
- Demonstrated understanding of various types of mechanisms, materials, proper tolerancing, drafting standards, design for mold ability and GD&T are required.
- Demonstrated background in developing creative solutions to solve design problems.
- Must demonstrate a strong initiative and follow through in executing projectresponsibilities, overcoming obstacles and balancing multiple priorities effectively.
- Must have experience leading and influencing others without authority, participating on cross functional teams and solid negotiating skills to bring products from concept to launch is required.
- Must have experience communicating concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams, and work effectively as a project leader.
- Experience utilizing computer aided design (CAD) to develop a product is required
- Process experience/six sigma training preferred.
PHYSICAL AND ENVIRONMENTAL DEMANDS:
- Well lighted, heated/or air-conditioned indoor office/production setting with adequate ventilation.
- Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
- Ability to maneuver throughout the facility/facilities as needed.
- Manual dexterity sufficient to reach/handle items and work with fingers.
- Weight limit occasionally up to twenty-five pounds.
- Ability to wear proper PPE