Process Engineer II

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Process Engineer II is an intermediate level engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing operating specifications and implementing and improving manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality. This position ensures process stability with a focus on maximizing safety, quality, yields, and productivity and requires collaboration with cross functional team to assess risk, disposition product, and resolve problems. Duties Include:

Proficient at maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques. Able to diagnose and resolve intermediate level process problems.

Exchanges ideas with other team members and leads technical discussions to realize process improvements and changes.

Leads decision making by building consensus among cross functional peers.

Proficient at evaluating and implementing process improvements or changes and driving a cross functional team to meet deadlines.

Independently conducts intermediate-level Process Engineering assessments using data to ensure proper product disposition, leads or supports Root Cause Analysis (RCA) and CAPA initiatives with robust, preventive solutions, and demonstrates strong technical writing skills and a solid understanding of cGMP standards.

Leads capital equipment purchases by generating robust justifications, managing timelines and spend activities, and overseeing fabrication, installation, and testing to meet industry and user requirements; generates, reviews, and approves engineering, manufacturing, and quality procedures to support equipment validation, launch, and production operations.

Coordinates equipment and process validations activities, including protocol and report writing, review and execution.

Designs and develops statistically controlled manufacturing processes, leads change requests to align implementation with operational and quality standards, advances systems to mitigate failure modes and scrap risk, navigates implementation challenges, and fosters effective teamwork by mentoring and collaborating across levels.

Physical Requirements

Physical flexibility to interact with and troubleshoot machinery and equipment.

Exposure to chemical reagents.

Sit, stand, and walk for extended periods of time.

Frequent lifting/carrying of 11-25 lbs., Occasional lifting/carrying of 26 - 50 lbs.

Bend, squat, stoop, and kneel.

Pinch, grasp, and manipulate objects consistently and regularly.

Excellent fine motor skills.

Who You Are

Minimum Qualifications

Bachelor’s Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or Controls Engineering.

2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Preferred Qualifications

Masters of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.

2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Electro-Mechanical, instrument and pneumatic knowledge along with 3+ years of experience applying this knowledge to process/equipment design and/or troubleshooting.

Proven ability to analyze intermediate level data sets, apply statistical analysis principles, and clearly summarize conclusions/results.

Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.

Read and understand intermediate level mechanical and electrical drawings and P&IDs.

Experience with Microsoft products, Minitab, and CAD software packages.

Understand safe work practices and experience in lockout, tag out, electrical safety, etc.

Lean/Six Sigma experience, with green or black belt.

Pay Range for this position: $77,900.00 - $130,900 .00 Annually

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!