R&D Engineering
Nesco Resource
Maple Plain, MN
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JOB DETAILS
SALARY
$30–$35 Per Hour
SKILLS
3D Printing, Analysis Skills, Best Practices, Biomedicine, Bridge Building, Business Support, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), CNC (Computerized Numerical Control) Systems, Cleanroom, Cross-Functional, Data Analysis, Design Verification, Detail Oriented, Documentation, Documentation Review, Establish Priorities, Experiment Design, FDA (Food and Drug Administration), Hand Tools, Healthcare Quality, ISO (International Organization for Standardization), Identify Issues, Implants, Interpersonal Skills, Lift/Move 30 Pounds, Maintain Compliance, Manufacturing, Mechanical Engineering, Mechanical Testing, Medical Equipment, Metrology, Minitab, Multitasking, Orthopedics, Patient Safety, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Product Engineering, Product Safety, Product Support, Production Support, Project/Program Management, Prototyping, Purchasing/Procurement, Quality Assurance Methodology, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Research & Development (R&D), Safety/Work Safety, SolidWorks, Standard Operating Procedures (SOP), Startup, Statistics, Strength of Materials, Supply Chain, Support Documentation, Technical/Engineering Design, Test Equipment, Testing, Time Management, United States Department of Energy (DOE), Writing Skills
LOCATION
Maple Plain, MN
POSTED
11 days ago
Workplace Type: Onsite 100%
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
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
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
About the Company
N
Nesco Resource
Companies need talent. You want job opportunities.
That’s where we come in. We create meaningful connections between companies and candidates, and we’ve been doing it for over 65 years.
Our national workforce solutions include contract, contract-to-hire, direct placement services, and managed services for a variety of industries.
We employ specialized recruiters focused in Engineering, Information Technology, Accounting & Finance, Administrative & Customer Service, and Manufacturing & Distribution.
When you need to find a job, we're your partner.
COMPANY SIZE
10,000 employees or moreINDUSTRY
Staffing/Employment Agencies
EMPLOYEE BENEFITS
Paid Sick Days, Parking, Performance Bonus, Employee Referral Program
FOUNDED
1956
WEBSITE
https://nescoresource.com/