Job Description
Title: Mechanical Engineer II
Location: St. Paul, MN 55117 (100% Onsite)
Duration: 05 Months
Shift: 8:00 AM – 5:00PM
Top 3-5 Skills or work type experience:
- Solidworks modeling experience
- Experience with Injection Molding
- Mechanical testing in a lab (Tensile, flex, HALT)
Description:
- Performs system design of capital equipment devices. Selects components, processes and proposes design alternatives.
- Designs hardware to support features that are contained in the product definition. Develops hardware design specifications and is responsible for technology selection.
- Assists the product definition team with feature selection.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Completes component and system designs using Solidworks. This includes setting and revising requirements and specifications, developing bill of materials, and completing documentation to ensure feasibility and verification of design performance.
- Plans, coordinates, and assists in executing the activities of development teams in support of project goals.
- Effectively communicates the project successes, risks, and roadblocks to the appropriate management levels.
- Performs analysis of the product using both empirical and computational models to help identify and mitigate product and project risks
- Conceptualizes new designs using technical expertise and innovative approaches.
- Interfaces with various internal functions, outside consultants, vendors, and the medical community.
- Supports animal studies, bench testing, clinical evaluations, and production
- Supports technical and design reviews
- Leads and contributes to strategic initiatives for continuous improvement
- Solves complex and diverse technical problems by applying sound judgment, creativity, appropriate data analysis, and technical expertise.
- Establishes product requirements and specifications, including justification and supportive testing to the requirements and specifications, conferring with suppliers to understand manufacturing limits and refine product requirements
Required
- Bachelor’s degree in Mechanical Engineering or other related Engineering field
- 4+ years of relevant hardware design, development, and testing experience, including a general familiarity with manufacturing equipment/processes that are compatible with highly reliable electronic medical or similar devices.
- Proficient in 3-D CAD utilizing Solidworks
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Experience with metals (machining, forming) and plastics (molding, machining, forming)
Preferred
- Familiarity with IEC 60601 family of standards
- Knowledge of electronics
- Medical Device experience
- Demonstrated ability to develop completely new designs and new design features as part of existing systems.
- Demonstrated ability to learn new skills quickly and perform developed skills with a high level of quality.
- Ability to develop and implement novel product concepts as part of new or existing systems.
- Ability to deliver research information which adds value to management’s decision-making process.
- Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications.
- Statistical analysis, or similar tool sets are preferred
- Training and experience in manufacturing processes and methods and in the manufacturing of medical devices desired.
- Experience with manual mills, lathes and other fabrication equipment
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
Job Tags
For contractors, Flexible hours, Shift work,