Process Engineer II

About the 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. This role involves establishing operating specifications, implementing and improving manufacturing techniques, and closely monitoring performance of machinery, automated equipment, and tools to verify efficiency. The position ensures process stability with a focus on maximizing safety, quality, yields, and productivity through collaboration with cross-functional teams to assess risk, disposition product, and resolve problems.

Responsibilities

• Maintain efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
• Diagnose and resolve intermediate-level process problems.
• Exchange ideas with team members and lead technical discussions to realize process improvements and changes.
• Build consensus among cross-functional peers to support decision-making.
• Evaluate and implement process improvements or changes, driving cross-functional teams to meet deadlines.
• Independently conduct intermediate-level Process Engineering assessments using data to ensure proper product disposition.
• Lead or support Root Cause Analysis (RCA) and CAPA initiatives with robust, preventive solutions.
• Demonstrate strong technical writing skills and a solid understanding of cGMP standards.
• Lead capital equipment purchases by generating robust justifications, managing timelines and spend activities, and overseeing fabrication, installation, and testing.
• Generate, review, and approve engineering, manufacturing, and quality procedures to support equipment validation, launch, and production operations.
• Coordinate equipment and process validation activities, including protocol and report writing, review, and execution.
• Design and develop statistically controlled manufacturing processes.
• Lead change requests to align implementation with operational and quality standards.
• Advance systems to mitigate failure modes and scrap risk, navigate implementation challenges, and foster 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.

Qualifications

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

• Master’s 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.
• Ability to read and understand intermediate-level mechanical and electrical drawings and P&IDs.
• Experience with Microsoft products, Minitab, and CAD software packages.
• Understanding of safe work practices and experience in lockout, tag out, electrical safety, etc.
• Lean/Six Sigma experience, with green or black belt certification.

Pay

Pay range for this position: $77,900.00 - $130,900.00 annually. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. This position may be eligible for sales or performance-based bonuses.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement plan (RSREMD)

We offer a culture of inclusion and belonging that empowers everyone to develop and grow at their own pace. Join us in building an environment that impacts millions and champions human progress.