Demo

Senior Manufacturing Engineer - Sterile Packaging

Medtronic
Warsaw, IN Full Time
POSTED ON 3/29/2025
AVAILABLE BEFORE 4/28/2025
We anticipate the application window for this opening will close on - 21 Mar 2025

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Senior Manufacturing Engineer, you will be responsible for developing manufacturing methods and leading continuous improvement activities for assembly, product finishing, packaging and clean room operations.

The position also coordinates the introduction of new products and processes to the production floor insuring the timely introduction of capable/proven processes.

As the Sr. Manufacturing Engineer, you will:

  • Be responsible for the development of all metal finishing, assembly and packaging methods for assigned product lines.
  • Partner with Project Engineer and determine Make vs. Buy decisions.
  • Participate during print review, partner with Quality Engineering on determining gages and measurement procedures.
  • Creates conceptual designs for new fixtures, gages and special cutting tools. Conducts tool design reviews with Tooling Team personnel, purchasing personnel and outside tool suppliers.
  • May determine appropriate machine platform for product and review any necessary capital equipment requirements.
  • May represent Warsaw on new product launch activities and transfer of product.
  • Completes activities of the change control policy and Corrective and Preventive Action (CAPA) system in accordance with Medtronic Corporate CAPA system.
  • Completes activities of Lean Sigma projects and process improvements
  • Review product drawings for manufacturability. Initiate drawing changes with the product design engineer to improve manufacturing quality and reduce costs.
  • Provide periodic updates of assigned projects to senior management, maintain project documentation, project plans, action item registers and actively manage risks related to cost, quality and schedule.
  • Partner with Quality during risk management activities. May lead and/or actively participate in design reviews, i.e.: DFMEA & pFMEA
  • Provide technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
  • Develop the manufacturing plan for new products and coordinates the entry of Manufacturing Process Planning information into the MRP system.
  • Proactively execute and support development of validation/qualifications studies. Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
  • Develop manufacturing setup/process sheets for all assembly, and finishing operations for new products.
  • Review engineering drawing changes and make/initiate appropriate changes in manufacturing tools, fixtures, processes, programs, bills of material or routings. Documents all changes through the Manufacturing Engineering process control system.
  • Resolve technical production problems on assigned product lines in finishing and assembly and packaging operations working with shop employees and quality personnel.
  • Conduct technical manufacturing reviews of suppliers to support purchasing personnel certifying suppliers.
  • May make recommendations to management on plant layout.
  • May recommend and implement plant equipment acquisitions. Work with equipment suppliers on equipment specifications, quoting of specified equipment and delivery schedules.
  • Initiate and direct improvements in current manufacturing methods and processes to improve past quality schedule performance and to reduce manufacturing costs.
  • May lead in the training of new Team personnel.
  • Train shop employees on new manufacturing methods, products and new production equipment.
  • Travel as required for company business transactions.
  • Support product launch and core business initiatives by utilizing project management tools. Seek resources, track and communicate status of product launch, provide solutions to launch issues and opportunities. Collaborate with key stakeholders to ensure smooth transition of design from concept to delivery.
  • Ensure processes and procedures are in compliance with regulations (21 CFR 820).
  • Performs other duties as assigned.


Must Have: Minimum Requirements

  • Bachelors degree required and a minimum of 4 years of relevant experience OR an advanced degree with a minimum of 2 years relevant experience


Nice to Have

  • Clean room monitoring and control experience
  • RO/DI water system support and troubleshooting experience
  • Sterile packaging experience
  • 5 years of Manufacturing Engineering experience
  • GDP/GMP
  • Validation planning and execution experience
  • Process mapping/Control plan Generation
  • Ability to review and update drawings
  • Experience with creation of FMEAs
  • Statistical analysis using (e.g.) Minitab
  • CAD experience such as Creo, NX, Autocad etc
  • Working Knowledge of Agile Map
  • Experience using SAP
  • Experienced in Supplier Engagement and support
  • Experience working in Medical Device Industry and with 13485/FDA requirements


Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$97,600.00 - $146,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

About Medtronic

Medtronic benefits and compensation plans

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000 passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

Salary : $97,600 - $146,400

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