Manufacturing Engineer

About the role

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).

Responsibilities

• Process Development & Built-In Quality: Lead the 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 where applicable, Right-sized and ergonomically optimized workstations, Task segmentation to reduce complexity and rework, 5S workplace organization and visual controls, Integration of poka-yoke (error-proofing) mechanisms, Design and release work instructions, process documentation, and in-process controls to ensure repeatable and scalable manufacturing.
• Continuous Improvement & Lean Manufacturing: Drive continuous improvement initiatives using Lean tools (e.g., value stream mapping, standard work, visual management). Conduct time and motion studies, line balancing, and workstation optimization to improve efficiency and reduce waste. Support tier-based escalation and visual factory systems to monitor and resolve Safety, Quality, Delivery, and Cost (SQDC) issues on the floor. Implement data-driven process controls to reduce variability and increase yield. Lead root cause investigations and corrective actions (CAPA) to address systemic production issues.
• New Product Introduction (NPI) & Client Integration: Act as the manufacturing lead for NPI, owning process development and validation deliverables throughout the product lifecycle. Collaborate with R&D, client engineering, and internal stakeholders to ensure design-for-manufacturability (DFM), smooth design transfer, and process readiness. Define and execute NPI activities such as PFMEA, pilot build support, validation plans, and readiness reviews. Serve as the technical point of contact for client engagements, audits, and feedback loops related to manufacturability and scalability.
• Documentation, Change Control & Compliance: Maintain controlled documentation including work instructions, BOMs, test protocols, and validation records in accordance with ISO 13485 and FDA 21 CFR 820. Initiate and process Engineering Change Orders (ECOs) and Document Change Orders (DCOs) to ensure technical documentation is up to date and reflects approved changes. Ensure robust configuration control across drawings, specifications, and revision history. Own or support Nonconformance Reports (NCRs) by conducting root cause analysis, implementing containment and corrective actions, and collaborating with Quality and Production. Participate in or lead Material Review Boards (MRBs) to disposition nonconforming material and drive resolution.
• Cross-Functional Collaboration: Work closely with Quality, Supply Chain, Planning, and Production teams to resolve issues, implement improvements, and meet customer and regulatory requirements. Translate client product requirements into manufacturable solutions and operational procedures. 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 continuous improvement initiatives across departments. Contribute to the development and tracking of engineering and production metrics in alignment with SQDC performance indicators. Support tier-based daily management systems to ensure timely escalation, resolution, and communication of key operational issues.

Requirements

• Education & Experience: Typically requires 2+ years of experience, and a mechanical, electrical or industrial engineering Bachelor’s degree from four-year College or university, or the equivalent combination of education, experience and training that provides the required knowledge, skills and abilities.

Skills and Abilities

• Knowledge of manufacturing principles including 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 processes.
• Ability to support NPI from prototype through production and engage directly with clients on design transfer and manufacturability.
• Effective in cross-functional collaboration and tiered issue escalation aligned with SQDC (Safety, Quality, Delivery, Cost) performance metrics.
• Proficient in CAD (SolidWorks preferred), ERP/document control systems, and MS Office; experience with test automation or simulation tools is a plus.
• Strong communication, problem-solving, presentation, and mentorship skills.

Benefits

In addition to base salary, Ascential offers a comprehensive benefits package. This includes health insurance, retirement plans, paid time off, and more.