Pay Range: 27-37/hr

depending on exp

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

Planet Pharma

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