Senior Manufacturing Engineer

Innovative Health LLC • Scottsdale, AZ

18d

About The Position

The Senior Manufacturing Engineer ensures the successful development, validation, and optimization of manufacturing processes for medical devices. The role drives continuous improvement, supports new product introductions, and maintains compliance with regulatory and quality standards. It combines technical expertise and hands-on manufacturing experience with cross-functional collaboration to improve product quality, process efficiency, and production scalability in a regulated environment.

The position works with R&D, Quality, and Regulatory teams on product transfers, scale-up, and validation, and provides technical leadership for new product introductions and design-for-manufacturability assessments. It also supports equipment selection, qualification, and maintenance planning, and mentors junior engineers and manufacturing associates. The role has no supervisory responsibilities.

Work takes place in office and manufacturing settings. The employee routinely uses standard office equipment and is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts, vibration, and potentially loud noise. Physical duties include regularly talking or hearing; frequently standing, walking, handling objects, and reaching; and occasionally sitting, climbing or balancing, stooping, kneeling, crouching, crawling, and lifting or moving up to 20 pounds. 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 track record 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.
• Lean Six Sigma certification at Green Belt level or higher.
• Ability to work independently and as part of a cross-functional team.

Nice To Haves

• Master's degree.

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 (SPC) 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 (CAPA) to improve yield and reduce scrap.
• Support equipment selection, qualification, and maintenance planning for critical manufacturing operations.
• Provide technical leadership on cross-functional teams for new product introductions (NPI) and design-for-manufacturability (DFM) assessments.
• Mentor junior engineers and manufacturing associates.

What This Job Offers

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