12181BR

Title:

Staff Engineer, Quality Production Support (NPI)

Job Description:

Lead Quality Engineering Projects to support the manufacture of medical devices. Work with Manufacturing and R&D Engineering teams to support manufacturing process changes, resolve product quality issues, and support the implementation of new products. Job duties:

• Work with Manufacturing Engineers on process changes, process improvement, and cost reduction projects, potentially leading the project.

• Lead projects in improving effectiveness and efficiency of assembly inspection activities and cross-functional system-related processes.

• Lead effort to resolve product quality issues.

• Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), equipment calibration, internal auditing, and quality metrics data analysis.

• Provide technical skill in many areas of quality engineering such as nonconformances, evaluating inspection data, evaluating process changes, implementing risk analysis, performing test method validations, and analyzing data.

• Review component and assembly nonconformance’s and provide direction in material review board.

• Work with Supplier Quality Manager/Engineers and suppliers to maintain high quality level of incoming production materials, as necessary.

• Support process and test method validation by developing, executing, or reviewing test protocols and reports.

• Coordinate implementation of new equipment and maintenance of existing equipment by reviewing equipment specifications and related qualification (IQ/OQ) reports and unscheduled maintenance reports.

• Support internal and external audits by participating preparation activities and addressing audits findings.

• Work with R&D, Manufacturing Engineers, Regulatory, and Supply Chain Planner to support implementation of new products on production floor.

• Work with R&D and Manufacturing Engineers to develop, review, and update risk analysis documents including product risk assessments and FMEA documents such as pFMEA.

• Supervise technical activities of Technicians and Engineers involved in quality engineering.

• Largely self-directed and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.

• Some travel required (approximately 10%).

• Perform other duties and responsibilities as assigned.

Auto req ID:

12181BR

Location:

Aliso Viejo, California, USA

Department Name:

321-Production Support Quality Assurance

Qualifications:

1. Bachelor’s degree in Engineering or related field.

2. Minimum of six (6) to eight (8) or more years of engineering experience in medical device or other regulated manufacturing industry.

3. Strong interpersonal and written and verbal communication skills.

4. Strong mathematics and proficient computer skills including MS Word, Excel, Outlook, and statistical tools including Statistical Software (e.g., MiniTab, Statgraphic, Design of Experiment DOE, etc.).

Desired Qualifications

1. Ability to provide technical leadership in process validation, test method validation, data analysis, risk analysis, change control, design control, design verification, and design validation.

2. Strong knowledge of medical product quality assurance (including the requirements for test protocols, test reports, and statistical techniques).

3. Ability to understand the technology related to MicroVention’s products.

External-Facing Title:

Staff Engineer, Quality Production Support (NPI)

Posting Country:

US - United States

Salary Range:

$99,266 - $142,972 (Compensation could be higher based on education, experience 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.