Engineer II, Process Development, R&D

Position Summary

Collaborate with Design Development, Product, and Manufacturing Engineers to define the design and processes for new products that meet the clinical needs.

Principal Responsibilities

• Specify, design, characterize, optimize, and implement manufacturing processes that are capable of meeting design, quality, productivity, and cost requirements.
• Investigate and troubleshoot process issues, determine causes, and implement solutions.
• Develop and implement easy-to-follow work instructions to produce products that meet requirements.
• Establish project timelines, track progress, manage to the schedule, and communicate project status to management and the project leader.
• Generate product development process documentation (e.g., PFMEAs, characterization studies, protocols, reports, MPs, Design Transfer reports, etc.).
• Plan, coordinate, and execute process validations. Transfer validated processes and equipment into production for commercial manufacturing.
• Coordinate with production to produce initial finished goods inventory for new product launches.
• Perform test data analysis. 
• Conduct risk analysis, failure analysis, and root cause investigations and report the results.
• Coordinate and execute product development builds.
• Build partnerships and collaborate with others to meet shared objectives.
• Work effectively in a diverse group, respect different ideas, perspectives, and values.

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required
• Minimum of 2+ years of relevant experience

Specialized Skills / Other Requirements

• Experience with design and process risk management documents (DFMEA/PFMEA).
• Understands various manufacturing and/or assembly processes.
• A knack for independent problem-solving of mechanical and/or electrical systems.
• Persistent in achieving success.
• Experience using Minitab to perform data analysis.
• Demonstrated project management skills and ability to coordinate multiple projects simultaneously.

TRAVEL REQUIRED: up to 25%

The pay range for this position at commencement of employment is expected to be between $79,400- $119,100; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental, and vision insurance, flexible spending accounts, participation in a 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability, and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, the employee will be in an “at-will position,” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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