Manager, Manufacturing Engineering

Coopervision

Stafford (TX)

On-site

USD 90,000 - 120,000

Full time

14 days+

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Benefits offered by this job

Medical coverage

401(k)

Parental leave

Paid time off

Other company perks

Job summary

Coopervision is seeking a Manager, Manufacturing Engineering at their Stafford, TX, location. The ideal candidate will lead engineering efforts for the production of medical devices, ensuring compliance with quality standards.

Responsibilities include managing engineering projects, improving manufacturing processes, and leading a team of engineers. A Bachelor's Degree in Engineering and substantial experience in the Medical Device sector are required.

Benefits include medical coverage and paid time off.

Qualifications

5+ years of experience in Medical Device Engineering or Technology.
Strong background in injection molding, tooling, and automation.
Managerial experience for a minimum of 3 years.

Responsibilities

Lead engineering support for manufacturing of medical devices.
Drive root-cause analysis and corrective measures.
Manage engineering projects and lead the engineering team.

Skills

New product launches

Supplier controls

Root-cause analysis

ISO 13485 knowledge

Lean Six Sigma experience

English and Spanish fluency

Education

Bachelor’s Degree in Engineering

5 years in Medical Device Engineering

3-5 years management experience

Tools

SolidWorks

Microsoft Office Suite

CAD

Job description

Work location: Stafford, TX (on-site)

Scope

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.

Job Summary

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.

Responsibilities

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.

Qualifications

Knowledge, Skills and Abilities:

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.

Experience:

Six‑Sigma methodology (DOE, Process Capability, Gage R&R, etc.).
Lean methodology to drive equipment and processing improvements/production efficiency.
Knowledge of SolidWorks and experience with ASME Y14.5, ISO and GD&T standards.
Maintain thorough understanding of the clinical use/risk of the product.
Thorough understanding of strength of materials, kinematics and dynamics, vibration, and fluid flow, as well as automation, plastic injection molding, part assembly, fixturing, testing and process control techniques.
Knowledge of the Medical Device Industry and familiarity with associated regulations.
Excellent problem‑solving and analytical ability.

Education:

Bachelor’s Degree in Engineering or Technology.
5 years of experience in Medical Device Engineering/Technology.
3‑5 years management experience.
Strong injection molding, tooling and automation background preferred.

Benefits

Benefits include medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and other company perks.

Equal Employment Opportunity

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

Job Info