Mechanical Engineer II

Position Title: Mechanical Engineer II

Work Location: St. Paul, MN 55117

Assignment Duration: 5 months

Work Schedule: M-F / 8am-5pm

Work Arrangement: 100 Percent Onsite

Position Summary: Performs system design of capital equipment devices, selecting components, processes, and proposing design alternatives.

Background & Context:

• Designs hardware to support features contained in the product definition.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

• 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.
• 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.

• 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).
• Familiarity with IEC 60601 family of standards (Preferred).
• Knowledge of electronics (Preferred).
• Medical Device experience (Preferred).
• Demonstrated ability to develop completely new designs and new design features as part of existing systems (Preferred).
• Demonstrated ability to learn new skills quickly and perform developed skills with a high level of quality (Preferred).
• Ability to develop and implement novel product concepts as part of new or existing systems (Preferred).
• Ability to deliver research information which adds value to management's decision-making process (Preferred).
• Demonstrated personal computer skills, including spreadsheet, word processing, database management, and specialized applications (Preferred).
• Statistical analysis, or similar tool sets are preferred.
• Training and experience in manufacturing processes and methods and in the manufacturing of medical devices desired (Preferred).
• Experience with manual mills, lathes and other fabrication equipment (Preferred).
• 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.