Manager, Manufacturing Engineering

Work location:

Stafford, TX (on-site)

The Manager, Manufacturing Engineering will provide leadership for multiple technical personnel and play a major role in projects that encompass production scale up and high-volume manufacturing at the Stafford TX manufacturing site. Provide Engineering support for the site’s core competency of molding, machining, assembly, and packaging of medical devices.

The Manager, Manufacturing Engineering provides leadership and technical support to ensure development of efficient and effective methods that support production of medical devices with highest quality in compliance with engineering specifications, FDA and GMP guidelines.

• Support production and ensure the continuity of manufacturing operations. Drive root‑cause analysis for non‑conformance, long‑term corrective actions, and preventive measures. Evaluate and correct systemic issues.
• Work with Manufacturing and Maintenance personnel to improve performance of manufacturing systems, i.e. yield improvements, scrap reduction, MUV reduction, cycle time improvements, ergonomic issues and maintenance needs.
• Spearhead initiatives for continuous process and lean implementations. Assess yield issues and promote design and/or selection of equipment to reduce costs and improve quality.
• Manage all stages of multiple engineering projects. Promote attainment of organizational objectives through team members.
• Provide leadership and guidance for non‑routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria.
• Work with vendors and internal departments to obtain necessary resources, resolve inter‑departmental issues and contribute toward organizational objectives.
• Provide direct management to a team of Engineers/Engineering staff, determine priorities based on business needs and resource availability.
• Conduct project/team meetings to resolve issues, determine current status, provide information and assess changes in priorities.
• Oversee preparation of documentation associated with engineering activities to include drawings/schematics, validation/capability testing, and various new and revised operating procedures. Provide reports and presentations to management as required.
• Generate timelines and milestones to bring projects to completion on time and within budget.
• Model company values and support strategic initiatives.
• Perform other related duties as assigned or required.

• Successfully completed numerous new product launches and product design changes in the medical device field.
• Demonstrated working knowledge of supplier controls, process validation, failure investigation techniques, root‑cause analysis, corrective/preventive action procedures, and protocol/report generation.
• Understanding of ISO 13485 requirements, medical device validations, and regulatory requirements.
• Computer skills:
  Microsoft Word, Excel, Project, PowerPoint, PLM system, CAD.
• Superb oral and written communication skills including presentation skills.
• Ability to work in a team/partnership environment.
• Black Belt/Green Belt certification or Lean Six Sigma experience desired.
• Language fluency in English and Spanish.
• 5 days per week in the office at Cooper Surgical location in Stafford, TX.
• Occasionally lift up to 40 lbs.
• Prolonged sitting in front of a computer.

• Six‑Sigma methodology (DOE, Process Capability, Gage R&R, etc.).
• Lean methodology to drive equipment and processing improvements/production efficiency.
• Knowledge of Solid Works and experience with ASME Y14.5, ISO and GD&T standards.
• Maintain thorough understanding of the clinical use/risk of the product.
• Thorough…