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Job Details

Senior Manufacturing Engineer

Location
Boulder, CO, United States

Posted on
Mar 01, 2022

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**Careers that Change Lives**
Impact patient outcomes. Come for a job, stay for a career.
We are looking for a senior manufacturing engineering professional who is proficient in complex electromechanical products and manufacturing operations and who excels in leadership behaviors and is looking to stand out and demonstrate their leadership and technical abilities.
As a Contract Manufacturing Senior Engineer, you will be managing the technical relationship with partner manufacturers, acting as a liaison between the external manufacturer and Medtronic operations and business functions. You will have Manufacturing sustaining engineering responsibility for complex electromagnetic medical device systems that may include X-ray and Robotic technologies produced in contract manufacturing locations around the world. As a seasoned engineer, you will be expected to work independently yet collaboratively, coach and review lower level and peer work, understand multiple issues and specialties, communicate expertly with internal and external partners and manage projects of large complexity.
**A Day in the Life**
Consistently deliver proactive high-quality manufacturing & service line support and react with a sense of urgency, providing thorough resolutions when issues arise
Designs and sustains manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
Evaluate and feedback to development on contract manufacturability and integration of new product introductions and transfers
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance
Manage change orders affecting product and process for implementation at our contract manufacturers
Manage BOMs and DMR for sustaining manufacturing
Resolve emergent technical issues, provide troubleshooting, failure (root cause) analysis and provide permanent solutions
Responsible for on time product delivery, quality and cost
Initiate and execute continuous improvement activities to improve product quality, reduce manufacturing costs, and reduce manufacturing process cycle time
Establish process and equipment performance metrics, monitoring performance trends, and maintaining and improving manufacturing efficiency.
Participate in product design review and ensure design for manufacturability and all requirement specifications are met
Ensures processes and procedures are in compliance with regulations
Sustain contract manufacturing processes, testers, fixtures, and equipment
Lead qualification and validation of new products, equipment, and processes activities at manufacturing site; write and execute engineering study/verification/validation protocols and reports, and standard operation procedures (SOPs) and routers.
Create and maintain pFMEAs; close assigned CAPAs and resolve/disposition QNs in a timely manner
Participate in vendor and supplier selection and qualification process to ensure they meet companys quality standards, technical requirements, and supply demand
Participate in FDA inspections, ISO Certifications and internal and external customer audits.
Establish a safe, secure, controlled and efficient operating environment.
**Must Have: Minimum Requirements**
Bachelors degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
**Nice to Have**
5 years of medical device manufacturing experience with 2 years of Contract Manufacturing experience
Electrical engineering degree or relevant experience with complex electromechanical products, test systems and solutions ability to interact and partner with electrical and system design engineers
Must be familiar with Food and Drug Administration (FDA) Good Manufacturing Practices (GMP) requirements, ISO 13485 standards and Occupational Safety and Health Administration (OSHA) requirements.
Strong analytical and problem-solving skills utilizing a structured methodology, ability to recommend and/or implement timely solutions to resolve technical problems in a manufacturing environment are required.
Proven track record of delivering results across a variety of experiences
Excellent written and verbal communication skills are essential.
Excellent project management skills are required. Work well under pressure. Ability to deliver on commitments and to meet deadlines on several projects simultaneously is required
Must be able to work in a team environment, able to work well with a diverse group of people both within the organization as well as with people outside the company.
Must be proficient in creating and understanding Bill of Material (BOM), engineering drawings, schematics, specifications, tolerance and standard operation procedures (SOP).
Familiar with product and process Verification and Validation in regulated environment.Experience with and understanding of manufacturing technologies
Computer literacy required; must be proficient in Microsoft Office and Mintab
Must be self-motivated, and have ability to work under minimal supervision; Mentor and train others.
Knowledge with Six Sigma and/or Lean Manufacturing, experience in SPC, statistical analysis, DoE and sampling are required.
Experience with ERP/MRP and/or SAP and Agile PLM experience is preferred.
Travel may be required up to 25%
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
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. (ADA-United States of America)
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.
Categories
Healthcare
Manufacturing / Production
Engineering
Administrative / Clerical
Financial Services
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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