As a Manufacturing Engineer I, II, or III, you will play a crucial role in the development and manufacturing of Class III medical devices. You will be responsible for executing engineering activities, including but not limited to device and process development, design verification and validation, process validation, equipment troubleshooting, line balancing, and layout design to ensure the successful development and launch of new products for our clients.

 

Organizational Competencies & Cultural Values:
The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.

Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

 

General Competencies:

• Knowledge of the strict regulatory guidelines and standards involved in developing and manufacturing class III medical devices.
• Problem-solving, root cause analysis, and troubleshooting to quickly propose and implement effective solutions to technical problems.
• Project management skills, including planning, coordinating, and resourcing tasks amongst cross-functional teams.
• Strong communication skills are critical in this role to present technical information to non-technical stakeholders, teams, and clients.
• Continuous learning and adaptability to stay updated on industry trends and advancements to drive innovation in product development and streamline manufacturing processes.
• Tool design and development, tolerance stack-up analysis, First Article inspection.

 

All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Successful employees take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

 

Essential Job Functions: 

• Develop and implement manufacturing processes for new and existing products, ensuring compliance with FDA and other regulatory requirements.
• Collaborate with design and development teams to ensure manufacturability and cost-effectiveness of new products.
• Conduct process validations and design transfer activities.
• Identify and implement process improvements to reduce waste, increase efficiency, quality, and reduce costs.
• Lead and/or contribute to continuous improvement initiatives.
• Provide training, technical support, and guidance to the manufacturing team.
• Troubleshoot and resolve production issues to maintain stable and efficient manufacturing operations.
• Develop and maintain manufacturing documentation, including work instructions, procedures, and specifications.
• Stay updated with industry trends, technologies, and regulations related to medical device manufacturing.

Education and Experience:

• Bachelor’s degree in manufacturing, mechanical, industrial, biomedical engineering or a related field.
• Minimum of 2-5 years of experience in manufacturing engineering, preferably in the medical device industry.
• 6S, Six Sigma, Kaizen, and/or Lean Manufacturing experience.
• Disposition of non-conformances and CAPA investigations.
• Strong understanding of FDA and ISO regulations for medical device manufacturing.
• Experience with designing and developing manufacturing processes and equipment.
• Knowledge of statistical process control and process validation requirements.
• Excellent problem-solving, root cause analysis, and analytical skills.
• Strong technical writing skills.
• Experience with CAD software, specifically Solidworks, and design verification/validation.
• Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

 

Physical Demands:

• Ability to work under stereo microscope, building miniature assemblies.
• Ability to tolerate filter laser light/flashing lights and high magnetic fields.
• Ability to sit or stand for long periods of time.
• Ability to lift, bend or move up to 50 pounds.
• Ability to adjust work schedule to meet deadlines and deliverables.

Compensation:

• $72,000 to $115,000 Annually to start, depending upon experience
• Paid Vacation
• Paid Holidays
• Paid Sick Leave
• Partial Payment by Company of Group Health, Dental, and Vision Insurance
• 401(k) with limited company matching