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Engineering
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20000EFB Requisition #
Careers that Change Lives

SUMMARY OF POSITION: 
The Senior Manufacturing Engineer is a key Operations representative within the North Haven Shared Service Engineering Group. The Senior ME will be responsible for completing tasks which support the strategic, compliance and cost savings initiatives  for the business. General responsibilities include manufacturing process evaluation, mechanical product knowledge & troubleshooting, and overall support of in-house manufacturing products and processes. Conduct engineering studies and MSA’s to support process validation and contribute to maximizing production performance. Provide engineering evaluations for cost savings initiatives which include but are not limited to production assembly equipment, methods and process validation of new and existing products. Collaborate on project teams to develop high quality, high reliability and highly manufacturable medical devices for Medtronic. Work under the direction of the Engineering Manager in a fast paced collaborative environment supporting program initiatives and compliant with company best practices. 


ESSENTIAL FUNCTIONS: 
• Contribute to continuous improvements in overall product quality and cost
• Participate in DFM / DFA activities assuring that production processes /equipment are taken into consideration 
• Maintain documentation associated with manufacturing processes. 
• Provide technical support for production tools including assembly equipment and automation. 
• Follow established guidelines and management direction with regard to engineering decisions. 
• Lead and execute projects with minimal supervision and the ability to plan and document projects.
• Advise leadership of developments which may affect profit, schedule and costs. 
• Participate on projects to concurrently develop assembly methods, tooling, equipment and processes for new and existing products. 
• Partner with Manufacturing to develop lean principals to implement solutions for product assembly. 
• Knowledge of Process Validations including protocol development and execution. 
• Support project team members in achieving business objects related attainment of Safety, Quality, Service, Cost and Project Schedule goals.
• Prepare and generate Capital Expenditure Requests (CER) for projects and track spend for both capital and expense dollars.
• Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities. (IQ, OQ, PQ)
• Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR's and CAPA. 
• Support manufacturing implementation and facility transfer while providing technical support to receiving facility.
• Complete on time project updates, project hours, development plans, self-assessments, and successful completion of all training requirements. 
• Knowledge of  of statistical and analytical methods such as SPC, SQC and DOE. 

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: 
• Some may be required 
• Continue to enhance engineering and leadership skills through additional training and education. 

A Day in the Life 

Responsibilities may include the following and other duties may be assigned.

  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.
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
Experience:
• Medical device, pharmaceutical or related industry preferred. Broad knowledge of Mechanical /Manufacturing Engineering.  Applicable Experience.

Skills/Competencies:
• Dynamic, positive attitude 
• Strong communication, manufacturing process, product industrialization and leadership skills. 
• Solid design, troubleshooting and presentation skills 
• Knowledge of Lean and/or 6 Sigma 
• Knowledge of GD&T 
• Knowledge of DFMEA and PFMEA

Skills/Qualifications:
• Strong Leadership and Project Management Skills 
• Knowledge and Experience with product assembly and Manufacturing methods/equipment (ie: Ultrasonic Welding, Crimping, Molding, MIM, Leak Test, Machine Controls and Vision Systems. 
• Knowledge and Experience with material process and testing. 
• Experience with AGILE
• Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC 
• Experience with DFEMA
• Excellent organization, Planning, Computer skills, Technical writing, Communication and Presentation skills.
• Strong Interpersonal Skills 
• Strong Computer skills

Additionally Preferred:
• Medical Device Background/ IOS 13485 
• Strong communication, manufacturing process and product industrialization skills
• Strong leadership skills
• Strong presentation skills
• Capital & Expense Management
• Ability to lead a cross-functional team
• Positive attitude, strong communication skills, and a self-starter
• Knowledge of RS Logic, FTP sites, and Maximo
• Knowledge of labeling systems such as Loftware and Prisym

ORGANIZATIONAL RELATIONSHIPS/SCOPE:
• Close-working interface with all areas of operations  and inter-departmental functions in support of compliance and cost savings initiatives

WORKING CONDITIONS: 
• Standard office setting, Clean room manufacturing area.

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. Let’s 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)

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