Position Summary: The Design Engineer is responsible for researching, designing and developing medical products (implants and instruments) within the assigned business unit, using CAD to generate electronic 3D Models. Those models will be verified to work as intended and subsequently turn into a specification print.
ESSENTIAL DUTIES & RESPONSIBILITIES:- Using computer software and complex 3D mathematical models to design, develop and test new material, devices and equipment. This can involve building and evaluating prototypes; troubleshooting problems; and rethinking the design until it works correctly.
- Utilizing parametric techniques, sketcher, spreadsheets, freeform, and assembly tools within the 3D software supported by OPSB.
- Liaising with technicians and manufacturers to ensure the feasibility of a product in terms of design and economic viability.
- Discussing and solving problems with manufacturing, quality, purchasing and marketing departments.
- Creating and completing Functional Relationship Analysis (FRA) and the associated Protocols, Reports, and Layouts in the defined conditions.
- Applying current ISO 13485, GD&T, and ASME standards to engineering prints.
- Work in a strong team environment.
- Use of Master Control as a database to store and link required documentation.
- Performs all other duties as assigned by manager.
QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be provided to enable individuals with disabilities to perform the essential functions).
- Ability to adjust priorities and manage time wisely in a fast-paced environment.
- Maintain documents and records pertaining to research and development.
- Communicate and work well with customers.
- Read, listen and communicate effectively in English, both verbally and written.
- Be results oriented, requiring knowledge and experience in a wide variety of disciplines.
- Ability to travel as needed.
- Work independently with minimal direction.
- Demonstrate problem solving skills with high proficiency.
EDUCATION AND/OR EXPERIENCE:- Requires a 2-year technical degree; BS strongly preferred.
- Five (5)+ years related engineering/design experience.
- Broad machine design experience. Broad exposure to metal and plastic fabrication technologies.
- Proven skills with defined CAD packages. Ability to use ISO 13485 design controls and regulations related to projects, which result in meeting global regulatory guidelines and policies.
- Good verbal and written (MS Word) communication skills. Medical device development experience preferred.
The above statements reflect the general details necessary to describe the principal functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.
Benefits Offered for Eligible Employees: - Long & Short-Term Disability
- Paid Time Off (PTO) & Holidays
The pay range for this role is:
80,000 - 110,000 USD per year (Stoughton )
