Pay Range: 27-37/hr
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
