Component Engineer

Oversee supplier quality for manufacturing processes with a focus on metal injection molding, compliance, and process optimization in a regulated medical device environment.

---

Job Requirements:

• BS degree in Mechanical or Biomedical Engineering or equivalent experience (advanced degree preferred)

• 4+ years of experience in engineering and manufacturing involving MIM, machined metals, or plastic injection molding

• Experience implementing Lean, Six Sigma, or SPC programs at supplier sites

• Strong project management skills

• Knowledge of 21 CFR Part 820 and ISO 13485

• Proficiency with Windows, Word, Excel, Project, Access, and ERP systems (SAP or Agile preferred)

• Ability to read and interpret mechanical drawings using GD&T

• Willingness to travel domestically and internationally up to 25%

---

Preferred Skills:

• Hands-on experience with metal injection molding

• Background in high-volume medical device manufacturing

• Familiarity with CAD and 3D modeling tools

• Proficiency with statistical analysis tools such as Minitab

• Proven success in supplier motivation and quality improvement initiatives

• Experience across various manufacturing processes (metal fabrication, plastics, electronics, or contract manufacturing)

---

Job Responsibilities:

• Manage supplier quality performance and drive continuous improvement initiatives

• Ensure supplier compliance with quality system regulations and industry standards

• Conduct supplier audits and risk assessments

• Lead implementation of Lean, Six Sigma, and SPC tools at supplier facilities

• Review technical drawings and specifications to ensure supplier product compliance

• Collaborate with cross-functional teams to support new product introductions and ongoing manufacturing needs

• Analyze manufacturing process capabilities and identify key variables impacting quality, cost, and capacity

• Utilize ERP systems to track and manage supplier quality data

• Prepare and present reports on supplier performance and quality metrics

Pay Details: $41.00 to $55.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance