Sr. Manager, Operations, CADI jobs in United States
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Getinge · 3 weeks ago

Sr. Manager, Operations, CADI

Getinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a Senior Manager, Operations to lead the Cardiac Assist Disposables Manufacturing Operations, ensuring timely execution of supply to Sales and Service Units while improving efficiency and quality standards.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Manage manufacturing operations of the Cardia Assist Disposables and Post-Quality-Packing manufacturing areas to meet planned production schedules. Work with Shipping, Quality and Planning Departments to coordinate production completion with order demand. Prepare manpower projections and capacity studies by measuring production performance against stated schedules, monitor and meet efficiency goals and manage changes to workplace
Production planning – manages the production planning for disposable business
PQP Shipping – manage the shipping for the balloon process
CADI Receiving Inspection – manage the incoming and in-process inspections and team (comprised of a manager, inspectors and engineers)
Assure all ISO/FDA/GMP requirements are in compliance through training, proper documentation, audits of manufacturing operations and improvements of manufacturing process. Ensure all manufacturing documentation are current and maintain required traceability
Implement changes to production operations based on Manufacturing Engineering and/or R&D designs and improvements, equipment implementation or other changes to current operations
Identify and develop plans to control and lower production costs, including labor, materials, and overtime. Coordinate activities with Manufacturing Engineering, Quality Assurance and Maintenance to achieve these goals
Develop supervisors to take a more active role in identifying and solving operational problems, process improvements and scrap reduction. Provide guidance to Supervisors on employee discipline and other HR processes assuring consistent implementation of company policies and guidelines
Work on cross-functional teams and works closely with Manufacturing Engineering, R&D and Quality Control in their support of Production operations. Lead effort in solving Operations problems, manage first analysis of failure data from floor and field for problem solving and quality improvements
Work closely with Sustaining Engineering and R&D to support Operations Service and Purchasing Departments
Provide support in completing engineering projects such as enhancements to existing product lines or to implement cost reductions or design changes
Evaluate customer complaints and solve corresponding problems as required
Provide oversight to the cycle counting effort to execute and investigate variances to eliminate re-occurring problems
Prepare budgets for financial planning
Assure compliance with all safety regulations set forth by the company

Qualification

Manufacturing Operations ManagementISO/FDA/GMP ComplianceProduction PlanningBudget ManagementClean Room PracticesProblem SolvingComputer LiteracyElectronics BackgroundLeadership SkillsInterpersonal SkillsOrganizational Skills

Required

10-15 years of experience in manufacturing and/or engineering management
Minimum of 5 years managerial experience required
Must have work experience in a highly regulated environment with thorough knowledge of ISO/FDA/GMP requirements
Understanding of clean room practices and batch manufacturing
Strong leadership skills required
Strong interpersonal skills to interact with people at all levels of the organization in either one-on-one or group settings
Problem solving skills to lead effort of engineering groups in solving manufacturing and/or design issues
Organizational skills to coordinate efforts of Engineering and Production Departments to achieve common goals
Computer literacy and ability to use electronic tools for inventory management, production schedule, device history trace ability and prints/drawings/procedures
Ability to read prints, drawings, and schematics
Strong organizational skills necessary to handle a variety of concurrent tasks
Strong problem-solving skills needed
Interpersonal management and leadership skills required for training for developing and leading all members of manufacturing organization

Preferred

Bachelor's degree preferred or equivalent combination of experience and education
Medical device field is preferred
Electronics background a plus

Benefits

Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement

Company

Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.

H1B Sponsorship

Getinge has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)

Funding

Current Stage
Public Company
Total Funding
$539.31M
2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO

Leadership Team

C
Christoffer Å.
Chief Information Security Officer
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Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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Company data provided by crunchbase