R&D Engineering-Jr

Title: R&D Component Engineer
Location: Maple Plain, MN
Duration: 06+ months
Pay rate: $33/hr - $36/hr

Top 3 Skills
1. Inspection experience
2. Qualification experience
3. Evaluation for disposition for components experience

About This Role:
This is an exciting opportunity for a well-rounded engineer to join a small team supporting a recently acquired medical device startup. The R&D Component Engineer I will be a key member of the engineering team, partnering with representatives from R&D, Quality, Supply Chain, and Production. This position is responsible for evaluating and dispositioning mechanical components used in the manufacturing scale up of Integrity Orthopaedic, Inc products. The R&D Component Engineer I acts as the technical bridge between design, procurement, and manufacturing, ensuring every mechanical part that goes into the instruments will be functional, reliable, compliant, and cost-effective.

In all actions, the R&D Component Engineer I shall demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented processes and procedures.

Your Responsibilities Will Include:
" Evaluating and approving parts to ensure compliance with requirements
" Inspect, analyze, 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
" Create and support documentation activities including, but not limited to: drawings and specifications for piece parts and assemblies; generate change orders to existing documents; review documentation generated by others related to product responsibilities; actively participate in design reviews; document the appropriate development and manufacturing practices per quality system or internal requirements; and verify all final design documentation, parts lists, and drawings to ensure compliance and accuracy
" 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

Other
" Ability to lift up to 30 pounds
" Must be able to wear clean room clothing and work in a cleanroom environment as needed

Equipment
" Laser scanning
" Micro View