Sr Process Engineer - Exempt, Santa Ana

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.