"Alerted.org

13037BR

Title:

Staff Engineer, Chemical Manufacturing

Job Description:

Responsible for leading and managing complex chemistry related projects in medical device product development, production, and maintenance. Design and optimize chemical processes to large-scale industrial manufacturing, including developing chemical flow diagrams and determining equipment specification while considering safety, efficiency, cost, and environment impact. Guide and mentor the chemistry manufacturing team and other departments in resolving chemical manufacturing and production issues, improving engineering and project systems, and identifying and resolving system deficiencies. Job duties:

+ Lead and manage improvement/development/transfer of chemical projects. Support existing chemical manufacturing processes, new products, product changes, line extensions, enhancements, and related tooling and fixture development and/or improvements.

+ Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.).

+ Draft and execute validation of chemistry product, equipment, and processes.

+ Lead collaboration with other departments to solve manufacturing production issues.

+ Manage equipment maintenance program and monitor sustainment health metrics.

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

+ Analyze data and improve processes to ensure robust/repeatable manufacturing processes.

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

+ Manage process validation and product transfer activities across different manufacturing facilities.

+ Investigate and test product processes and identify and review system deficiencies (e.g., NCR’s, DC, EO’s, etc.).

+ Identify and execute improvements, issues, or any process requirement with minimum supervision.

+ 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:

13037BR

Location MV:

Aliso Viejo, California, USA

Department Name:

320-Indirect Manufacturing

Qualifications:

1. Bachelor of Science in Chemical Engineering, Chemistry, Chemical Sciences, or a related field of study.

2. A minimum of six (6) years of relevant chemical, pharmaceutical, and/or medical device manufacturing experience.

3. Strong written and verbal communication skills.

4. Proficient computer skills including Microsoft Office Suite: Excel, PowerPoint, Outlook, Word, and Teams.

5. Ability to use and apply lean management principles to initiate, analyze, improve, and create engineering projects and quality procurement systems.

6. Ability to prioritize and meet deadlines in a timely manner.

7. Comprehensive knowledge of safe handling of chemical components, solution and mixtures when developing large-scale industrial manufacturing processes.

Desired Qualifications

1. Master’s degree in chemical engineering, Chemistry, Chemical Sciences, or a related field of study.

2. A minimum of eight (8) years of experience in leading medical device and/or pharmaceutical development through various advanced engineering and analytical approaches.

3. Expert in Design of Experiments (DOE) for road mapping full chemical characterization and processes during development and optimization stages.

4. Statistical knowledge (Green Belt or Black Belt) in Design of Experiments (DOE) and Process Capability Cpk for process development characterization and optimization.

External-Facing Title:

Staff Engineer, Chemical Manufacturing

Posting Country:

US - United States

Salary Range:

$111,000 - $138,000 (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.