12591BR

Title:

Principal Engineer, NPI & Transfers

Job Description:

Responsible for leading robust manufacturing process development and enhancement in medical devices for both existing and new product development, production, and processes by applying system-level understanding of the entire process lifecycle, from R&D to full-scale manufacturing. Working closely with R&D to create manufacturing specifications, maintain and enhance manufacturing processes, oversee design of fixtures and equipment, validate test methods, and select raw materials to ensure that the concepts and prototypes meet their specifications. Lead process development projects related to new product introductions, existing process improvement and engineering to improve product quality and yields, and other engineering tasks. Evaluate, initiate, and establish improved engineering and process validation. Work closely with Manufacturing, Quality, Regulatory, and global Marketing teams internally and outside vendors and consultants. Job duties:

• Serve as the technical lead for manufacturing process development and improvement for existing processes, new products, product changes, line extensions, enhancements, and related tooling and fixtures.

• Design, lead and execute equipment and process validations.

• Lead the design, development, and optimization of manufacturing processes for new or existing medical devices.

• Apply methodologies like Design of Experiments (DOE) and Statistical Process Control (SPC) to establish and refine manufacturing processes.

• Evaluate and improve existing in-process inspection methods by implementing vision systems for identifying defects and reducing scrap.

• Collaborate with other departments to oversee multiple process improvements to ensure readiness for process validation and alignment with company goals.

• Evaluate, create, and initiate improvements to existing engineering and project systems. Drive root cause investigations related to product and process failures.

• Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.

• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.

• Set up and initiate new manufacturing pilot line(s), including purchasing, implementing, and validating new equipment.

• Review and develop manufacturing documents (e.g., MP, BOM, pFMEA, etc.) in equipment mechanical design.

• Seek and implement innovative technologies to enhance manufacturing processes and equipment design.

• Establish systems for monitoring production processes to identify inefficiencies and develop strategies to reduce waste, improve yield, and enhance product quality.

• Lead, mentor, and support Engineers, Technicians, or others as needed.

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

• Perform additional duties as assigned.

Auto req ID:

12591BR

Location:

Aliso Viejo, California, USA

Department Name:

646-R&D Management

Qualifications:

1. Bachelor's degree in mechanical/manufacturing/industrial engineering or related field.

2. A minimum of ten (10) years of relevant manufacturing process development experience in the medical device industry.

3. Strong written and verbal communication skills.

4. Proficient computer skills including MS Word, Excel, Outlook, Teams, and CAD.

Desired Qualifications

1. Advanced degree in Engineering or related field.

2. A minimum of twelve (12) years of relevant manufacturing process development experience in the medical device industry.

3. Ability to design, develop, and validate manufacturing processes of medical devices and working knowledge of cGMP.

4. Knowledge of statistical tools including Design of Experiments (DOE) and experience with improving existing process capabilities and optimization.

5. Expertise in process design, optimization, and validation (IQ, OQ, PQ).

6. Proficiency with statistical tools (e.g., Minitab).

7. Hands-on experience with manufacturing processes involving hydrophilic coating, polymer fusing, and nitinol stents.

8. Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus).

9. Ability to solve complex manufacturing problems.

10. Ability to read and prepare technical documentation.

11. Knowledge of medical and technical development as well as international regulations for medical devices.

12. Strong problem solving and conflict management skills.

13. Proficiency with SolidWorks and fixture design preferred.

External-Facing Title:

Principal Engineer, NPI & Transfers

Posting Country:

US - United States

Salary Range:

$115,000 - $160,000 (Compensation could be higher/lower based on experience, education and skill sets)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.