R&D Component Engineer
Job
Actalent
Maple Plain, MN (In Person)
$93,600 Salary, Full-Time
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Job Description
Job Title:
R D Component Engineer Job Description 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 play a pivotal role in the engineering team, collaborating with representatives from R D, Quality, Supply Chain, and Production. This position is responsible for evaluating and managing mechanical components used in the manufacturing scale-up of products. The R D Component Engineer I serves as the technical bridge between design, procurement, and manufacturing, ensuring every mechanical part in our instruments is functional, reliable, compliant, and cost-effective. The role requires a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and other documented processes and procedures. Responsibilities Evaluate and approve parts to ensure compliance with requirements. Inspect, analyze, potentially rework, review, test, and disposition components to ensure functionality. Perform design and project tasks related to the inspection, testing, and production support of implantable orthopedic devices and non-implantable delivery instruments. Assist in research and development of new components, assemblies, and processes to support product development and continuation activities. Conduct dimensional, strength of materials, mechanism movement, and manufacturability analysis. Generate test methods and protocols, perform tests, analyze data, generate reports for product verification, and present findings to cross-functional stakeholders. Create and support documentation activities including drawings, specifications, change orders, and design reviews. Perform various product engineering tasks to support R D and operations. Communicate updates to the program manager and cross-functional team members regarding task completion and schedule adherence. Evaluate and solve technical challenges individually or as part of a team by collaborating cross-functionally. Participate in engineering meetings, technical working groups, and project management discussions. Assist in building, prototyping, modifying, and testing engineering components. Follow safety protocols, quality SOPs, and regulatory requirements in all tasks and activities. Document activities according to best engineering practices, company procedures, and regulatory requirements. Essential Skills 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 analytical methods including statistics, DOE, and associated software tools (Minitab). Strong problem-solving skills, attention to detail, and ability to work both independently and as a team. Self-starter with proven ability to work successfully with minimal supervision. Excellent teamwork and interpersonal skills. Good written and verbal communication skills. Ability to multitask, prioritize, and meet project deadlines with high attention to detail. Additional Skills & 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, with 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 environments. Work Environment The position is onsite with standard hours from 8-5. There may be some flexibility to accommodate traffic if necessary. The work involves supporting a tool used for rotator cuff surgery that is FDA approved, with current production around 100 units per month and plans to expand significantly in the next year. Job Type & Location This is a Contract position based out of Maple Plain, MN. Pay and Benefits The pay range for this position is $35.00 - $55.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Maple Plain,MN.
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