Component Engineer -- PATDC5758714

Job Tittle: R&D Component Engineer

Duration: 06-month contract

Location : Maple Plain, MN

Your Responsibilities Will Include:

• Evaluating and approving parts to ensure compliance with requirements

• Inspect, analyse, potentially rework, review, test and disposition components to ensure functionality

• Perform both design and project tasks related to the inspection, testing, and production support of implantable orthopedic devices and associated non-implantable delivery instruments

• Assist in research and development of new components, assemblies, and processes to support product development and continuation activities

• Perform dimensional, strength of materials, mechanism movement, and/or manufacturability analysis

• Generate test methods and protocols, perform tests, analyze data, generate reports for product verification, and present findings as needed to cross-functional stakeholders

• Perform various product engineering tasks as necessary to support R&D and operations

• Communicate updates to the program manager and other various cross-functional team members as it relates to task completion and schedule adherence relative to overall business goals and objectives

• Evaluate and solve technical challenges either individually or as part of a team by: collaborating cross-functionally to troubleshoot issues and implement solutions; actively participating in problem solving sessions and/or brainstorming; systemically and logically working through issues using personal skills/experience and/or pulling in resources as needed; and designing and conducting experimental testing to appropriately characterize and evaluate solutions

• Participate in engineering meetings, technical working groups, and project management discussions

• Assist in the building, prototyping, modifying, and testing of engineering components

• Assist with prototyping, assembling, characterizing, validating inspection processes, rework instructions, and/or test methods

• Follow safety protocols, quality SOP's, and regulatory requirements in all tasks and activities

• Comply with applicable design-related standards published by external regulatory bodies

• Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements

• Perform other duties as needed and assigned

Minimum Qualifications

• Bachelor's degree in engineering (Mechanical, Manufacturing, Industrial, Biomedical, or technical equivalent) with 0-3 years of related work experience or an equivalent combination

• Hands-on experience in metrology and familiarity with metrological equipment

• Experience in the use of analytical methods including statistics, DOE, and associated SW tools (Minitab)

• Strong problem-solving skills, attention to detail, and the ability to work both independently and as a team

• Self-starter with proven ability to successfully work with minimal supervision

• Desire to learn and meaningfully contribute to the team

• Good teamwork and interpersonal skills

• Good written and verbal communication

• Ability to multitask, prioritize, and meet project deadlines with high attention to detail

Preferred Qualifications

• Hands-on experience with prototyping tools (3D printing, hand and/or power tools, manual and/or CNC machining, etc.), measurement tools (Keyence, Micro-Vu), and mechanical testing equipment

• Working knowledge of current CAD tools, SolidWorks experience preferred

• Experience working within an ISO certified or FDA registered work environment

• Familiarity with medical device quality systems and regulations

• Demonstrated cross-functional teamwork in technically demanding environment

• Strong bias for action and ability to shift as needed to support changing business needs