SR. Manufacturing & Process Development Engineer

TE Connectivity Corporation; Plymouth (MN); On-site; USD 102,000 - 154,000; Full time

Job summary

Join a forward-thinking company as a Sr. Manufacturing & Process Development Engineer, where your expertise will drive innovation in medical device manufacturing. You will lead the design and implementation of cutting-edge manufacturing processes, ensuring compliance with industry standards while mentoring junior engineers. This role offers a unique opportunity to enhance production capabilities and contribute to a safer, sustainable future. With a competitive salary and a comprehensive benefits package, this position is perfect for those looking to make a significant impact in a dynamic environment.

Benefits

Health Insurance

401(k)

Disability Insurance

Life Insurance

Employee Stock Purchase Plan

Paid Time Off

Voluntary Benefits

Qualifications

• 5+ years in manufacturing engineering in medical devices.
• Expertise in CAD software and technical documentation.
• Certifications like Six Sigma Black Belt are desirable.

Responsibilities

• Lead design and qualification of new manufacturing equipment.
• Develop preventive maintenance programs for optimal performance.
• Collaborate with R&D for innovative production solutions.

Skills

CAD Software (SolidWorks)

Problem-Solving Skills

Communication Skills

Knowledge of FDA Regulations

Statistical Process Analysis

Education

Bachelor's Degree in Mechanical Engineering

Master's Degree in Biomedical Engineering

Tools

CNC Milling

PLC Programming

3D Printing

Job description

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SR. Manufacturing & Process Development Engineer

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Overview

The Sr. Manufacturing and Process Development Engineer plays a crucial role within the equipment and process engineering (EPE) team that serves TE’s Medical business unit. This position requires a blend of technical expertise, leadership skills, project management, and innovative thinking to drive manufacturing excellence and process optimization.

Key Responsibilities

• Conceptualization, design, build, test, installation, and qualification of new manufacturing equipment.
• Develop and implement preventive maintenance programs to ensure optimal equipment performance and longevity.
• Troubleshoot complex equipment issues and lead root cause analysis efforts.
• Innovation and Technology Integration (Primary)
  • Stay abreast of emerging technologies and industry trends in medical device manufacturing.
  • Propose and implement innovative solutions to enhance production capabilities and product quality.
  • Collaborate with R&D teams to ensure applicability and adaptability to new product designs.
• Team Leadership and Mentoring (Primary)
  • Provide technical guidance and mentorship to junior engineers and technicians.
  • Foster a culture of continuous improvement and knowledge sharing within the team.
  • Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.
• Process Development and Optimization (Secondary)
  • Lead the development and implementation of new manufacturing equipment & processes for medical catheter assemblies and components.
  • Continuously improve existing processes to enhance efficiency, quality, and cost-effectiveness.
  • Utilize advanced engineering principles and statistical methods (e.g., Six Sigma, Lean Manufacturing) to optimize production workflows.
• Project Management (Secondary)
  • Lead cross-functional teams in the execution of process improvement and equipment installation projects.
  • Manage project timelines, budgets, and resources effectively.
  • Communicate project status and results to stakeholders at all levels of the organization.
• Quality and Regulatory Compliance (Secondary)
  • Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines.
  • Develop and train standard operating procedures (SOPs) and work instructions.

What your background should look like:

• Bachelor's degree in Mechanical, Manufacturing, Automation, Biomedical Engineering, or related field;
• 5+ years of experience in manufacturing engineering within the medical device industry preferred.
• Expert with CAD software (SolidWorks) with solid proficiency in technical documentation, including solid modeling and engineering drawings.
• Experience with controls design, layout, and PLC programming preferred.
• Hands on experience with CNC milling, manual lathe, manual mill, 3D printing, etc. (Preferred)
• Excellent problem-solving skills
• Strong communication and interpersonal skills, with the ability to influence cross-functional teams.
• Knowledge of FDA regulations, ISO standards, OSHA standards, and GMP requirements for medical device manufacturing (Preferred).
• Proven expertise in process development, equipment engineering, and project management (Preferred).
• Understanding of statistical process analysis tools, including Design of Experiments (DOE) and Cpk for process development characterization and optimization (Preferred)
• Certifications such as Six Sigma Black Belt or Project Management Professional (PMP) are highly desirable.

Physical Requirements
• Extended periods of sitting or standing
• Extended periods working in a cleanroom environment
• Ability to lift 35 pounds
• Extended periods of computer usage

#TANAAB

ABOUTTE CONNECTIVITY
TE Connectivity is a global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, renewable energy, automated factories, data centers, medical technology and more. With more than 85,000 employees, including 8,000 engineers, working alongside customers in approximately 140 countries. TE ensures that EVERY CONNECTION COUNTS. Learn more atwww.te.com and onLinkedIn , Facebook , WeChat, Instagram and X (formerly Twitter).

COMPENSATION
• Competitive base salary commensurate with experience:$102,600 - $153,800 (subject to change dependent on physical location)
• Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity.
• Total Compensation = Base Salary + Incentive(s) + Benefits

BENEFITS
• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets

Location:

PLYMOUTH, MN, US, 55442

City: PLYMOUTH

State: MN

Country/Region: US

Travel: Less than 10%

Requisition ID: 133151

Alternative Locations:

Nearest Major Market: Minneapolis
Job Segment: Biomedical Engineering, Six Sigma Black Belt, Six Sigma, Lean Six Sigma, Manufacturing Engineer, Engineering, Management