Supplier Manufacturing Engineer

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.

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