Senior Manufacturing Engineer

The Senior Manufacturing Engineer plays a key role in ensuring the successful development, validation, and optimization of manufacturing processes for medical devices. This position is responsible for driving continuous improvement initiatives, supporting new product introductions (NPI), and maintaining compliance with regulatory and quality standards. The ideal candidate combines strong technical expertise with hands-on manufacturing experience and works cross-functionally to enhance product quality, process efficiency, and production scalability in a regulated environment.

Essential Duties and Responsibilities:

· Lead process design, development, and optimization activities for medical device manufacturing, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820.

· Drive continuous improvement initiatives using lean manufacturing, Six Sigma, and statistical process control (SPC) tools.

· Collaborate with R&D, Quality, and Regulatory teams to support product transfers, scale-up, and validation activities (IQ/OQ/PQ).

· Develop and implement robust process validation protocols and execute validation studies for new and existing processes.

· Analyze manufacturing data to identify trends, root causes, and corrective/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.

Supervisory Responsibilities:

· None

Education, Qualifications and Skills:

· Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, or related field (Master's preferred).

· 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.

· Proficient with engineering tools (e.g., SolidWorks, Minitab, JMP) and ERP/MES systems.

· Excellent communication, project management, and leadership skills.

· Lean Six Sigma certification (Green Belt or higher)

· Ability to work independently and within a cross-functional team.

Work Environment:

· This job operates in an office and manufacturing setting. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

· While performing the duties of this job, the employee is frequently exposed to odors, fumes, dust or airborne particles, moving mechanical parts and vibration. The noise level in the work environment and job sites can be loud.

· The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

· While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

· The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.