Senior Manufacturing Engineer

Innovative Health • Scottsdale, AZ

1d

About The Position

The Senior Manufacturing Engineer is responsible for developing, validating, and optimizing medical device manufacturing processes. The position drives continuous improvement, supports new product introductions, and maintains compliance with regulatory and quality standards. The engineer works cross-functionally to improve product quality, process efficiency, and production scalability in a regulated manufacturing environment.

The role includes leading process design and optimization, supporting product transfers and scale-up, conducting process validation, analyzing manufacturing data, and supporting equipment selection and qualification. It also provides technical leadership on cross-functional initiatives and mentorship to junior engineers and manufacturing associates. The position has no supervisory responsibilities.

Work takes place in office and manufacturing settings. The role routinely uses standard office equipment and may involve exposure to odors, fumes, dust or airborne particles, moving mechanical parts, vibration, and loud noise. Regular duties require talking or hearing, and frequently standing, walking, handling or feeling objects, and reaching. Occasional duties include sitting, climbing or balancing, stooping, kneeling, crouching, or crawling, and lifting or moving up to 20 pounds. Specific vision abilities include close, distance, color, and peripheral vision, depth perception, and adjusting focus.

Requirements

• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or a related field.
• At least 5 years of experience in a regulated medical device manufacturing environment.
• Strong knowledge of GMP, ISO 13485, and FDA regulations.
• Proven experience in process validation, root cause analysis, and implementing engineering controls.
• Experience with automation, assembly, or testing equipment in a cleanroom or controlled manufacturing environment.
• Proficiency with engineering tools such as SolidWorks, Minitab, or JMP, and with ERP/MES systems.
• Excellent communication, project management, and leadership skills.
• Ability to work independently and as part of a cross-functional team.

Nice To Haves

• Master's degree.
• Lean Six Sigma certification at Green Belt level or higher.

Responsibilities

• Lead medical device manufacturing process design, development, and optimization in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Drive continuous improvement using lean manufacturing, Six Sigma, and statistical process control tools.
• Collaborate with R&D, Quality, and Regulatory teams on product transfers, scale-up, and IQ/OQ/PQ validation activities.
• Develop process validation protocols and execute validation studies for new and existing processes.
• Analyze manufacturing data to identify trends and root causes and implement corrective and preventive actions to improve yield and reduce scrap.
• Support selection, qualification, and maintenance planning for equipment used in critical manufacturing operations.
• Provide technical leadership to cross-functional teams for new product introductions and design for manufacturability assessments.
• Mentor junior engineers and manufacturing associates.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior