Senior Manufacturing Engineer

This Jobot Job is hosted by: Tyler May
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Salary: $110,000 - $130,000 per year

A bit about us:

Our client is a specialized medical device manufacturer focused on innovative eye care products that support better vision and long-term ocular health. For more than three decades, this company has designed and produced a broad portfolio of ophthalmic and optometric supplies, instruments, and disposables used in procedures such as cataract, refractive, and dry eye treatments.

Operating from an ISO 13485-certified facility in Southern California, the organization maintains rigorous quality standards that align with U.S. and international medical device regulations. The manufacturing and quality systems are built to comply with 21 CFR 820 and comparable global requirements, allowing the company to serve clinicians and patients in both domestic and international markets.

This company partners closely with eye care professionals to continually refine how products are engineered, packaged, and delivered, ensuring they are reliable in the operating room and everyday clinical practice. With hundreds of SKUs spanning dry eye therapies, surgical accessories, and other vision care solutions, our client combines precision manufacturing with a mission-driven culture centered on improving patient outcomes.

Why join us?

Joining our client means stepping into a stable, growth-oriented medical device business where your engineering decisions have a direct impact on patient comfort and clinical results. You will own complex manufacturing processes for highly specialized ophthalmic products, giving you visibility across the full product life cycle-from concept and scale-up through sustained production and continuous improvement.

As a senior manufacturing engineer, you will collaborate daily with R&D, quality, operations, and regulatory teams in a close-knit environment where ideas can move quickly from the cleanroom to the customer. The company's ISO 13485-compliant environment offers the chance to deepen your experience with regulated manufacturing, validation, and documentation while still maintaining an agile, hands-on culture.

Our client offers a comprehensive benefits package typical of established medical manufacturers in the region, including health coverage, retirement plans, and paid time off, along with opportunities for professional development and cross-functional leadership. If you are motivated by building robust processes, solving problems on the production floor, and mentoring other engineers and technicians, this role provides the responsibility and support to grow your technical and leadership skills.

Job Details

Core responsibilities:

Lead the design, development, and optimization of manufacturing processes for ophthalmic medical devices and related components in a regulated environment.
Drive new product introduction (NPI) from an operations standpoint, including process definition, pilot builds, scale-up, and transition to full production.
Develop and maintain process documentation such as work instructions, standard operating procedures (SOPs), process flow diagrams, PFMEAs, and control plans in alignment with ISO 13485 and 21 CFR 820.
Analyze production data to improve yield, reduce scrap, and enhance process capability using statistical tools, root-cause analysis, and structured problem-solving methodologies.
Specify, qualify, and implement new equipment, tooling, and fixtures; lead IQ/OQ/PQ protocols and coordinate with quality and validation teams.
Provide day-to-day technical support to manufacturing, troubleshooting nonconformances and process deviations, and implementing both immediate containment and long-term corrective actions.
Collaborate with R&D to influence product designs for manufacturability, reliability, and cost-effectiveness while maintaining critical performance requirements for eye care applications.
Champion continuous improvement initiatives leveraging Lean and Six Sigma principles to shorten lead times, reduce costs, and standardize best practices across production lines.
Train and mentor operators, technicians, and junior engineers on new processes, equipment, and documentation requirements to ensure consistent execution on the floor.

Qualifications:

Bachelor's degree in mechanical engineering, manufacturing engineering, biomedical engineering, or a related technical discipline; an advanced degree is a plus.
5+ years of experience in manufacturing or process engineering, preferably in medical devices, pharmaceuticals, or other highly regulated, precision manufacturing environments.
Proven track record developing and sustaining processes under ISO 13485 or comparable quality management systems, with working knowledge of FDA quality system regulations (21 CFR 820).
Hands-on experience with process validation (IQ/OQ/PQ), equipment qualification, and statistical process control in a cleanroom or controlled manufacturing environment.
Demonstrated ability to use structured problem-solving tools (5 Whys, fishbone diagrams, DMAIC, DOE, etc.) to resolve complex production issues and improve capability.
Familiarity with Lean manufacturing concepts such as 5S, visual management, standard work, and flow optimization; Six Sigma certification is a plus.
Comfortable reading engineering drawings and specifications, including GD&T, and working with ERP and document control systems common to medical device manufacturers.
Strong communication skills, with the ability to interface effectively with production, quality, R&D, supply chain, and regulatory stakeholders.
Ability to manage multiple projects simultaneously, prioritize effectively in a fast-paced environment, and take ownership of deliverables with minimal supervision.

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