About the Role

At KARL STORZ, the Manufacturing Engineer, OR1 plays a critical role in supporting manufacturing operations, new product introductions, and continuous improvement initiatives for our OR1 integrated operating room product portfolio. This position partners closely with Engineering, Manufacturing, Quality, and Global Supply Chain teams to develop efficient, scalable manufacturing processes while ensuring the highest standards of quality, reliability, and operational excellence.

Key Responsibilities

Manufacturing Operations & New Product Introduction

• Support new product introductions (NPI) by developing manufacturing processes, validating tooling, creating standard operating procedures (SOPs), and ensuring manufacturing readiness.
• Evaluate product designs for manufacturability (DFM) and provide recommendations during the product development process.
• Support Make-or-Buy decisions through technical analysis and collaboration with cross-functional teams.
• Partner with Engineering, Manufacturing, and Supply Chain teams to successfully transfer new products into production.

Continuous Improvement

• Lead continuous improvement initiatives utilizing Lean Manufacturing, Just-in-Time (JIT), 5S, and other operational excellence methodologies.
• Improve production flow, equipment layouts, tooling, and manufacturing processes to increase efficiency and reduce waste.
• Identify opportunities for cost reduction while maintaining product quality and regulatory compliance.
• Support obsolescence management and manufacturing sustainability initiatives.

Manufacturing Support & Problem Solving

• Troubleshoot production and field issues through root cause analysis and implementation of corrective actions.
• Support supplier quality initiatives and collaborate with external vendors to resolve manufacturing challenges.
• Develop and implement process improvements that enhance product quality, manufacturability, and operational performance.
• Train manufacturing personnel on new processes, equipment, and work instructions.

Cross-Functional Collaboration

• Partner with Quality, Engineering, Manufacturing, and Global Supply Chain teams to ensure successful execution of manufacturing initiatives.
• Support process documentation, manufacturing standards, and operational best practices.
• Utilize approved AI-assisted development tools to improve documentation, process development, troubleshooting, and engineering productivity while complying with company policies, data privacy and information security requirements, quality system requirements, and all applicable legal and regulatory obligations.

Minimum Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, Electrical Engineering, or a related engineering discipline.
• 7+ years of manufacturing engineering experience in a regulated manufacturing environment.
• Experience supporting new product introductions (NPI) and manufacturing process development.
• Strong knowledge of Lean Manufacturing, 5S, Just-in-Time (JIT), and continuous improvement methodologies.
• Experience with mechanical and electrical assembly manufacturing processes.
• Proficiency with SolidWorks and Microsoft Office Suite.
• Strong analytical, troubleshooting, communication, and project management skills.
• Working knowledge of FDA, ISO 13485, and ISO 9001 quality systems.

Preferred

• Master's degree in Engineering or a related technical discipline.
• Lean Manufacturing and/or Six Sigma certification.
• Experience within the medical device industry.
• Experience supporting systems integration or complex electromechanical products.
• 10+ years of manufacturing engineering experience.

What You'll Need to Succeed

• Strong problem-solving and root cause analysis skills.
• Excellent organizational and project management abilities.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong cross-functional communication and collaboration skills.
• Commitment to quality, continuous improvement, and operational excellence.
• Passion for delivering innovative solutions that improve patient care.

What We Offer

• Competitive compensation and comprehensive benefits package
• Opportunities for career growth and professional development
• Collaborative, innovative, and mission-driven work environment
• Exposure to cutting-edge medical technologies
• The opportunity to improve patient outcomes through world-class engineering and manufacturing innovation

MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Eligible Employee Benefits

• Medical / Dental / Vision including a state-of-the-art wellness program and access to pet insurance, too!
• 3 weeks vacation accrual for full time roles,* paid holidays plus paid sick time too
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 66.67% (4%) of the employee's first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• HSA Savings Accounts with company contribution
• Life, STD & LTD Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!
  * Field sales, internships, and roles that are regularly scheduled to work less than 30 hours per week are not eligible for vacation, except where required by law.
  
  Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
  
  KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member's base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

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