Supplier Manufacturing Engineer
Location
Santa Clara, CA | United States
Job description
POSITION SUMMARY:
Works independently and/or cross-functionally to manage contract manufacturing partners and suppliers to ensure production operations and process development activities on new and existing products; ensures efficient and effective transfer of product into production for long term sustainability.
DUTIES & RESPONSIBILITIES:
- Works with internal teams to provide guidance on manufacturability, robustness, DFM, and process/supplier development during new product development and post market/sustaining support.
- Assesses contract manufacturer process capabilities, innovates, and implements process improvements for increased effectiveness.
- Conducts and supports Contract Manufacturer for the selection, installation, qualification (IQ/PQ/OQ) of tooling, equipment, processes, or software utilized in product manufacturing.
- Applies technical knowledge and statistical tools to develop, characterize, and optimize processes.
- Able to design and develop tooling fixtures and semi automated systems to aid in process manufacturability.
- Leads design transfer activities to external manufacturing partners, including cost analysis, process/supplier development, control of Manufacturing and Quality documentation.
- Creates design transfer plans and document project activities.
- Works with suppliers, purchasing and development to ensure design requirements are defined and met.
- Develops efficient process flow, manufacturing fixtures, and manufacturing work instructions.
- Executes the functional deliverables associated with Product development and Quality Systems. Assists in evaluating, resolving, and auditing quality issues.
- Supports new product development activities and product manufacturing transfer into production.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOMs, DMRs, Routers, Manufacturing Instructions, FMEAs, etc.)
- Generates documentation changes/justification through ECO process.
- Plans, organizes, and conducts all aspects of technical reviews.
- Writes and reviews validation protocols and reports applicable to new process improvements.
- Leads or assists in developing and implementing preventive and corrective action plans.
- Initiates continuous improvement and cost reduction projects throughout the company.
PREFERRED QUALIFICATIONS:
Preferred Requirements:
- Must have strong verbal and written communication skills and an ability to influence decision making.
- Must be a creative problem solver able identify and solve technical problems with suppliers.
- Must be able to 10% to 15% nationally and internationally.
- Proven results in reducing cycle time and improving labor efficiency.
- Ability to work in a fast-paced environment where priorities are dynamic; must have well developed task/activity prioritization optimization skills.
- Proficient in CAD system, SolidWorks preferred.
- Knowledge of Microsoft applications including MS Projects.
- Strong documentation skills, familiar with FDA requirements.
- Understanding of GMP requirements.
- Experience with production tools such as ECO process and demand flow preferred.
- An understanding of statistical software.
- Must have hands-on experience in process validation activities including IQ, OQ, PQ and tooling qualifications.
Preferred Education and/or Job experience:
- BS in Engineering/Technical field.
- 3+ years Medical Device experience preferred.
- Electro-mechanical experience is preferred.
- Experience with medical device disposable products and/or capital equipment is desirable.
Job tags
Salary