Manufacturing Engineer II

Job Title: Manufacturing Engineer II (Supplier Engineering)

Location: United States (Travel up to 20%)

Position Overview

The Manufacturing Engineer II (Supplier Engineering) serves as a key technical liaison between the company and its external manufacturing partners. This role is responsible for driving supplier performance, supporting product development initiatives, and ensuring robust, scalable manufacturing processes.

The ideal candidate will bring hands-on experience in manufacturing engineering, supplier collaboration, and process validation, with a strong foundation in regulated environments such as medical device, pharmaceutical, or biotech industries.

Key Responsibilities

Supplier Engineering & Technical Leadership

• Act as the primary technical point of contact for suppliers providing injection molded, extruded, electromechanical components, and complex sub-assemblies
• Lead recurring technical reviews with suppliers to manage engineering initiatives, including process validations, yield improvements, and capacity planning
• Collaborate with supplier engineering teams to analyze manufacturing processes and implement continuous improvement plans

Process Development & Validation

• Develop and execute process validation strategies (IQ/OQ/PQ) in partnership with suppliers
• Conduct risk assessments using FMEA and implement mitigation strategies
• Support root cause investigations and drive effective corrective and preventive actions (CAPA)

Product Development Support

• Serve as the supplier-facing engineering lead for new product development projects
• Partner with internal design teams to evaluate manufacturability and drive Design for Manufacturing/Test (DFM/DFT) improvements
• Support design changes through qualification planning, testing, and implementation

Quality & Compliance

• Partner with internal quality and inspection teams to investigate non-conformances and drive resolution
• Ensure supplier processes meet applicable regulatory and quality standards (e.g., FDA, ISO)
• Contribute to “Quality at the Source” initiatives with key suppliers

Project & Stakeholder Management

• Utilize project management tools to define milestones, track progress, and communicate deliverables
• Support supplier selection and second-source qualification activities
• Influence cross-functional teams by providing technical expertise and supplier insights

Qualifications

• Bachelor’s degree in Manufacturing Engineering, Plastics Engineering, Mechanical Engineering, or related field (Master’s preferred)
• 3 years of relevant manufacturing or supplier engineering experience, ideally within medical device, pharmaceutical, or biotech environments
• Experience supporting manufacturing of injection molded, extruded plastic components and/or electromechanical assemblies (e.g., PCBAs, cables, connectors, box builds)
• Working knowledge of process validation methodologies (IQ/OQ/PQ) and risk management tools (FMEA)
• Experience with root cause analysis and statistical process control (SPC) methods
• Familiarity with quality systems and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485)
• Basic metrology skills (e.g., calipers, gauges, optical comparators)

Preferred Qualifications

• Experience with SMT/PCB manufacturing and electronic assembly processes
• Knowledge of ERP systems (SAP preferred)
• Lean Six Sigma Green Belt or Black Belt certification
• Experience with Gauge R&R studies and advanced statistical analysis

Additional Requirements

• Ability to travel up to 20% domestically and internationally
• Strong communication, problem-solving, and cross-functional collaboration skills

Compensation

• Salary range: $79,000 – $127,650
• Offers are typically aligned near the midpoint of the range, based on experience and qualifications

Why This Role

This position offers the opportunity to work at the intersection of product development and manufacturing, driving meaningful improvements in supplier performance and product quality. It is well-suited for an engineer who enjoys hands-on problem solving, cross-functional collaboration, and making a tangible impact on manufacturing outcomes.