Manufacturing Engineer

ATR International; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

ATR International is seeking a Manufacturing Engineer / Process Engineer (Specialist) to lead critical projects in a medical device production setting, driving cost, safety, service continuity, and quality improvements.

You will design and optimize manufacturing processes, validate equipment, and mentor junior staff while partnering with design teams to ensure manufacturability and compliance with regulatory standards.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline with relevant experience.
• Advanced degree preferred with minimum years of relevant experience.
• Medical device manufacturing experience and project leadership skills.

Responsibilities

• Lead end-to-end projects focused on cost, safety, continuity, and quality.
• Design and optimize manufacturing processes and layouts.
• Oversee equipment selection, installation, qualification, and validation.
• Drive Lean Six Sigma initiatives and continuous improvement.
• Ensure manufacturability of designs and regulatory compliance.
• Communicate with senior stakeholders and mentor junior engineers.

Skills

Project management

Lean Six Sigma

Equipment qualification

Process validation

Design for manufacturability

Quality & compliance

Vendor interaction

Mentorship

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Job description

Job Title: Manufacturing Engineer / Process Engineer (Specialist)

Position Overview The Manufacturing Engineer leads critical projects focused on cost, safety, service continuity, and quality within a medical device production environment. This role drives the innovation, development, and optimization of existing manufacturing processes while ensuring full compliance with industry regulations. As a seasoned individual contributor, you will manage project budgets, timelines, and cross-functional resources while providing high-level technical support, coaching junior staff, and influencing key decision-makers.

Key Responsibilities

• Project Leadership & Execution: Lead and manage end-to-end projects focused on cost optimization, safety, business continuity, and quality assurance, ensuring deliverables stay within budget and timeline constraints.
• Process Design & Optimization: Design manufacturing processes, operational sequences, and production layouts for assemblies, equipment installation, machining, and material handling to maximize plant efficiency.
• Equipment & Process Validation: Oversee equipment selection, installation, qualification, and validation processes (IQ/OQ/PQ) to meet strict quality and regulatory standards.
• Continuous Improvement: Recommend and execute equipment and process modifications to boost yields, enhance production techniques, and implement Lean and Six Sigma methodologies.
• Design for Manufacturability: Partner with product design and development teams to ensure compatibility between product specs and manufacturing capabilities; adapt machine designs to factory conditions.
• Quality & Compliance: Develop processes aligned with statistical process control (SPC), inspect machinery performance, investigate deficiencies, and execute root-cause corrective actions.
• Stakeholder & Vendor Interaction: Communicate regularly with senior internal stakeholders, external customers, and vendors to exchange technical data, present recommendations, and influence decisions.
• Mentorship: Act as an expert resource, providing coaching, guidance, and technical oversight to lower-level engineers and specialists.

Qualifications & Experience

Basic Qualifications:

• Education & Experience: Bachelor’s degree in Engineering or a related technical discipline with a minimum of 4 years of relevant experience, OR an Advanced Degree (Master’s) with a minimum of 2 years of relevant experience.
• Industry Experience: Direct experience working within the medical device manufacturing industry.
• Project Management: Proven track record of independently leading cross-functional engineering projects from design through final implementation.
• Validation Expertise: Hands-on experience with equipment and process qualification/validation routines.

Top Required Technical Skills:

• Equipment and Process Validation (Medical Device Standards)
• Project Management (Demonstrated leadership of timelines, budgets, and resources)
• Lean Six Sigma application within a medical device production environment

Preferred Qualifications (Nice to Have):

• Formal Lean Six Sigma Certification (Green Belt or Black Belt).
• Experience with plant layout design, statistical process control (SPC), and advanced tooling/fixture development.

Working Style & Differentiating Factors

• Autonomy: Operates independently under limited supervision to determine project approaches and solutions.
• Impact: Direct responsibility over critical, complex manufacturing processes directly affecting organizational goals and performance.
• Problem Solving: Conducts in-depth analysis to resolve complex, multi-faceted engineering issues and drive continuous system improvements.