Manufacturing Engineer

Position Summary

The Manufacturing Engineer is a hands-on technical leader responsible for developing, improving, and sustaining manufacturing processes for regulated instruments and devices, including FDA Class II products. This role plays a critical part in driving operational excellence through built-in quality, lean manufacturing, structured new product introduction (NPI), and alignment with plant-level SQDC goals (Safety, Quality, Delivery, Cost). The ideal candidate thrives in a low- to mid-volume, high-mix environment and excels at cross-functional collaboration, process rigor, and systems thinking.

Essential Functions

• Process Development & Built-In Quality: Lead design, development, validation, and implementation of robust assembly and test processes, including IQ/OQ/PQ and equipment qualification. Apply Built-in Quality principles to manufacturing line design including single-piece flow, ergonomic workstations, task segmentation, 5S, visual controls, and poka-yoke. Design and release work instructions, process documentation, and in-process controls.
• Continuous Improvement & Lean Manufacturing: Drive initiatives using Lean tools (value stream mapping, standard work, visual management). Conduct time and motion studies, line balancing, and workstation optimization. Support tier-based escalation and visual factory systems for SQDC issues. Implement data-driven process controls to reduce variability and increase yield. Lead root cause investigations and corrective actions (CAPA).
• New Product Introduction & Client Integration: Act as manufacturing lead for NPI, owning process development and validation deliverables. Collaborate with R&D, client engineering, and internal stakeholders on DFM, design transfer, and process readiness. Define and execute PFMEA, pilot builds, validation plans, and readiness reviews. Serve as technical contact for client engagements, audits, and feedback on manufacturability.
• Documentation, Change Control & Compliance: Maintain controlled documentation (work instructions, BOMs, test protocols, validation records) per ISO 13485 and FDA 21 CFR 820. Initiate ECOs and DCOs. Ensure configuration control across drawings and specifications. Own or support NCRs with root cause analysis, containment, and corrective actions. Participate in or lead Material Review Boards.
• Cross-Functional Collaboration: Work with Quality, Supply Chain, Planning, and Production to resolve issues and meet requirements. Translate client product requirements into manufacturable solutions. Represent manufacturing in client meetings, audits, and design reviews.
• Leadership & Mentorship: Provide technical mentorship to junior engineers and manufacturing support staff. Lead Kaizen events, RCCA investigations, and improvement initiatives. Contribute to engineering and production metrics aligned with SQDC. Support tiered daily management systems for escalation and resolution.

Education & Experience

Typically requires 2+ years of experience and a Bachelor's degree in mechanical, electrical, or industrial engineering from a four-year college or university, or the equivalent combination of education, experience, and training that provides the required knowledge, skills, and abilities.

Job Complexity

Works on problems of diverse scope and high complexity, often with incomplete or ambiguous information. Requires in-depth analysis and strong understanding of manufacturing systems, regulatory constraints, and client expectations. Exercises sound judgment in selecting methods, techniques, and evaluation criteria. Independently drives initiatives while building strong internal and external relationships.

Knowledge, Skills & Abilities

• Knowledge of Lean, Built-in Quality, 5S, single-piece flow, poka-yoke, throughput, utilization, and process capability
• Skilled in PFMEA, control plans, process validation (IQ/OQ/PQ), and test method development
• Experienced with root cause analysis (8D, 5 Whys, fishbone), CAPA, SPC, Gage R&R, and risk-based quality tools
• Proficient in interpreting mechanical drawings, GD&T, electrical schematics, and BOMs
• Familiar with mechanical and electromechanical components (motors, gears, sensors, adhesives, fasteners, fluidic systems, optics systems, and PCBAs)
• Understanding of fabrication and assembly methods including machining, molding, welding, and surface treatments
• Knowledge of FDA 21 CFR 820, ISO 13485, and regulatory compliance practices (CE, UL)
• Experience with ECOs, DCOs, NCRs, MRB, and configuration control
• Ability to support NPI from prototype through production and engage with clients on design transfer
• Effective in cross-functional collaboration and tiered escalation aligned with SQDC metrics
• Proficient in CAD (SolidWorks preferred), ERP/document control systems, and MS Office; test automation or simulation tools a plus
• Strong communication, problem-solving, presentation, and mentorship skills

Effort Required

Primarily requires ability to sit at a desk and work on a computer for extended periods, including frequent keyboard use and electronic communication. Occasionally involves walking through production areas, standing during inspections or meetings, and lifting objects up to 25 pounds. Telephone communication may be required intermittently. Work environment includes both office and manufacturing floor settings with moderate noise level. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Travel

This position may require some travel for up to 10% of the time.

Pay

On-site position in San Diego with annual salary range of $90,000 - $110,000, based on experience and qualifications. Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.