Manufacturing & Process Development Engineer

ZipRecruiter; White Bear Lake (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in healthcare technology is seeking a Manufacturing / Process Development Engineer to support the launch of new medical devices. This role involves defining and validating manufacturing processes, collaborating across teams, and ensuring compliance with industry standards. Ideal candidates will have a Bachelor's degree in Mechanical Engineering and experience in medical device manufacturing. Growth opportunities are significant, offering exposure to various products and a chance to influence organizational development.

Benefits

Competitive salary

Health insurance

Life insurance

Retirement plans

Qualifications

• Experience with medical device manufacturing/development is a plus.
• Ability to work in a fast-paced environment focused on technical excellence.
• Knowledge of developing products within a QMS framework.

Responsibilities

• Define, verify, and validate new manufacturing processes.
• Collaborate with quality and engineering teams to ensure manufacturability.
• Identify and implement continuous improvements.

Skills

Critical thinking

Problem-solving

Technical writing

Mechanical aptitude

Communication

Organizational skills

Education

Bachelor’s degree in Mechanical Engineering

Job description

Job Description

Hemostasis Fiagon designs, develops, manufactures, and markets advanced hemostat, wound healing technologies, and medical devices for use in the healthcare industry supporting ENT. We are seeking a Manufacturing / Process Development Engineer to support our growth and the launch of new medical device products. Our products include PosiSep Hemostat Dressing and the VenSure Balloon Dilation System.

The ideal candidate will identify and implement process improvements across manufacturing areas and support manufacturing transfer projects. This role involves collaboration with research & development, operations, quality, regulatory, sales, and marketing teams to ensure successful product launches.

Growth opportunities are significant, offering exposure to various products and a chance to influence organizational development.

The responsibilities include:

1. Define, verify, and validate new manufacturing processes and design changes.
2. Perform engineering and quality analysis of processes and prototypes.
3. Develop and execute testing protocols, documenting results.
4. Collaborate with quality and engineering teams to ensure manufacturability.
5. Develop automation, fixtures, and equipment in collaboration with engineers.
6. Conduct equipment qualifications (IQ/OQ).
7. Participate in process validation activities.
8. Identify and implement continuous improvements.
9. Provide technical support for products as needed.
10. Lead or support projects and teams.
11. Ensure compliance with ISO 13485, FDA, and CE standards.
12. Maintain design history records per Hemostasis quality system.

Position requirements:

1. Bachelor’s degree in Mechanical Engineering or related field.
2. Experience with medical device manufacturing/development is a plus.
3. Ability to work in a fast-paced environment with a focus on technical excellence and innovation.
4. Mechanical aptitude for understanding and optimizing processes.
5. Strong technical writing skills.
6. Knowledge of developing products within a QMS framework.
7. Critical thinking and problem-solving skills.
8. Ability to manage multiple tasks and communicate effectively.
9. Strong organizational skills and attention to detail.
10. Excellent communication skills.

We value teamwork, entrepreneurial spirit, and professional development. Our benefits include competitive salary, health, life, and retirement plans.