Manufacturing Engineer

Manufacturing Engineer

Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Manufacturing Engineer to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics.

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 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.

Education, Experience,

Skills and Abilities

Required:

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.

Job Complexity:

Works on problems of diverse scope and high complexity, often with incomplete or ambiguous information. Requires in-depth analysis and a strong understanding of manufacturing systems, regulatory constraints, and client expectations. Exercises sound judgment in…