Sr Process Engineer, Santa Ana

Job Title: Sr Process Engineer

Location: 5290 California Ave Irvine CA 92617

Duration: 12 Months

Job ID: 19860

Pay Range: $50-55/HR

JOB DESCRIPTION

HM's Top Needs:

1. Previous medical device experience

2. Hands-on experience in manufacturing (preferably medical device)

3. Process validation experience

Education Required: Science/Engineering Degree: E2 (BS, MS)

Years’ Experience Required: E2 (min. 1-2 yrs)

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Work Location: Do they need to be local to any MDT office and if so where? Yes, Irvine (two different buildings)

Does this person need to be on site? If so, full time or part time? Onsite 3-5 days/week

Responsibilities:

Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects & assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

PRIMARY RESPONSIBILITIES:

Develop new manufacturing processes, procedures, inspection methods, and production layout for assemblies for New Product Introductions through frequent interaction with R&D, Quality Engineering, and Operations using project management, design for manufacturability, and lean methodologies.

Develop fixtures, tooling, and equipment.

Develop process specifications which 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, including training of operators, coordination with production planning, preparing manufacturing procedures and work orders, ordering materials, installing fixtures and equipment, supervising builds, and troubleshooting assembly issues.

Comply with applicable FDA and international regulatory laws/standards.

Perform other duties as assigned or required.

MINIMUM QUALIFICATIONS:

Bachelor’s degree in Engineering (preferably Mechanical, Electrical, or Biomedical)

2+ years of experience developing products and/or manufacturing processes in medical device industry

Knowledge of SolidWorks and engineering statistics

Good verbal and written communication skills

Computer literate; word processing, spreadsheets

PREFERRED QUALIFICATIONS:

Knowledge of processing materials associated with medical devices such as Polymers (nylons, polyethylene, polypropylene, PEEK, PTFE, FEP, etc.), and Metals (nitinol, platinum, stainless steel, etc.).

Hands-on experience with processes associated with medical manufacturing such as shrinking (reflow), laser bonding, laser welding, thermal bonding, adhesive bonding, braiding, coil winding, hydrophilic coating, plasma treatment, cleaning processes, crimping, heat setting, electropolishing, swagging, etc.

Experience with development and qualification of fixtures/tooling/equipment (IQ/OQ/PQ, support, design).

Experience working with outside OEM Suppliers in component development, and selection of equipment and processes.

Experience being on project teams tasked with new product development and successful transfer into manufacturing.

Knowledge of design and process FMECA, process validation, and process control.

Knowledge of design for manufacturability and lean methodologies.