Description
Job Title: R&D Component Engineer
Location: Maple Plain, MN- 100% onsite
Duration: 6 months with possible extensions
Pay: $32.00-$35.00 /HR
Position Summary:
•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 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 Orthopedics products.
•The R&D Component Engineer 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 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
Interview Process
• Teams interview with hiring manager
• Onsite tour of facility, meeting with some team members
Top 3 Skills
1. Inspection experience
2. Qualification experience
3. Evaluation for disposition for components experience
Equipment
• Laser scanning
• Micro View
Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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