Sr. Manufacturing Engineer

Description


Please note - Sponsorship or transfer of sponsorship, including OPT/F1 Visas, is not available for this role.

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

This position is primarily responsible for maintaining, developing, and implementing robust cost-effective manufacturing processes and methods in accordance with customer product specifications for components and assemblies to Class III medical device quality standards. Manufacturing Engineers document processes and could implement creative ideas or solutions to improve assembly operations which may include development of tooling/fixturing as needed to accomplish this task.

Key Responsibilities:

• Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements and efficiency from conception to fully established production.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance.
• Help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results.
• Prepare engineering change orders and coordinates the deployment of changes including training Operations team members.
• Perform product and process analysis for cost reduction, quality improvement and improved efficiency.
• Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions.
• Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations.
• Troubleshoot processes when defects occur. Help to determine root cause and implement effective containment and countermeasures.
• Active participant in Material Review Board (MRB). Help to lead Non-Conforming Material Report (NCMR) or customer complaint investigations.
• Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing.
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and requested production changes.
• Represent manufacturing on cross functional teams.
• Participate in Kaizens and drive improvement efforts.
• Attends, schedules, and leads project meetings to evaluate current and future process initiatives.

Must Have:

• A Bachelor's degree in a STEM engineering required. Advanced degree preferred
• At least 5 years of experience required in manufacturing engineering required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Advanced knowledge of manufacturing and assembly processes.
• Previous experience with the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling.
• Excellent verbal and written communication skills.
• Must be able to read, write and speak fluent English.
• Ability to lead, train, and engage manufacturing team members to reach Cirtec's quality standards.
• Must be able to read blueprints and interpret technical specifications and illustrations.
• The capacity to work well under pressure, change priorities on the fly, and take on new challenges.
• Project management skills and the ability to work to tight deadlines.
• Teamwork and people management skills.
• Experience associated with continuous improvement activities like participation in Kaizen events using lean manufacturing principles.
• A practical and logical approach to problem solving using lean six sigma concepts.
• Willingness to travel if required (<5%).

Good to have:

• Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred.
• Strong computer skills associated with MS Office suite, Minitab, and SolidWorks a plus.

Anticipated salary range: $95,000 to 127,000/year depending on qualifications and experience.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.