Sr Process Engineer - Exempt

LanceSoft Inc; Irvine (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in medical device manufacturing is seeking an experienced Process Engineer to enhance manufacturing processes. The role requires a strong background in engineering and hands-on experience in medical device production, focusing on process validation and compliance. Candidates should possess a Science or Engineering degree along with several years of relevant experience.

Qualifications

• Bachelor's or Master's degree in Science or Engineering.
• Minimum 3-4 years of relevant experience in process engineering, particularly in medical devices.

Responsibilities

• Provide technical support in manufacturing, recommend process improvements.
• Develop manufacturing processes and compliance with FDA standards.
• Lead development of new product introductions and manage projects.

Skills

Medical device experience

Process engineering

Process validation

Education

Science/Engineering Degree

Job description

We are seeking a highly skilled and experienced professional to join our team with a focus on medical device manufacturing. The ideal candidate will have a strong background in process engineering, particularly within the medical device industry, and will play a critical role in enhancing our manufacturing processes.

HM's Top Needs:

• Previous medical device experience
• Hands-on experience in manufacturing (preferably medical device)
• Process validation experience

Education Required:

Science/Engineering Degree: Sr (BS, MS)

Years’ Experience Required:

Sr (minimum 3-4 years)

Work Schedule:

40 hours a week, onsite 3-5 days/week in Irvine (two different buildings)

Responsibilities:

• Provide technical and sustaining engineering support in a manufacturing area.
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies.
• Integrate equipment and material capabilities to meet process module target specifications.
• Review product development requirements for compatibility with processing methods.
• Lead the innovation, development, and optimization of new manufacturing concepts, processes, and procedures.
• Develop manufacturing processes applicable to statistical process control.
• Ensure processes and procedures are in compliance with regulations.
• Formulate, deliver, and manage projects, working with stakeholders to achieve desired results.

Primary Responsibilities:

• Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions.
• Develop fixtures, tooling, and equipment.
• Develop process specifications to ensure user needs are met.
• Perform equipment and process characterizations and qualifications (IQ/OQ/PQ).
• Manage required builds for new product development in a pilot or production setting.
• Comply with applicable FDA and international regulatory laws/standards.

Preferred Qualifications:

• Knowledge of processing materials associated with medical devices such as Polymers and Metals.
• Hands-on experience with processes associated with medical manufacturing such as laser bonding and thermal bonding.
• Experience with manufacturing line layout, capacity analysis, and line balancing.
• Proficient with development and qualification of fixtures/tooling/equipment.
• Experience working with outside OEM Suppliers in component development.
• Experience with design and process FMECA, process validation, and process control.
• Knowledge of design for manufacturability and lean methodologies.