Manufacturing Engineer - Konik

Manufacturing Engineer
Minneapolis, MN | Direct Hire | $100k – $140k| Remote

Konik is partnering with a start up medical device company that is seeking to add an experienced Manufacturing Engineer to their team. In this position, you will play a key role in managing, guiding, and supporting contract manufacturing organizations and vendors for a mechanical medical device. If you are a skilled engineer with a background in medical device that would thrive in a cross-functional role, this is an excellent opportunity.

Manufacturing Engineer Responsibilities:

• Oversee and coordinate production activities with contract manufacturing organizations (CMOs) and component vendors to ensure product quality, adherence to timelines, and compliance with regulatory standards.
• Manage the setup, planning, and optimization of manual-assembly production lines, implementing best practices for efficiency and quality control in manufacturing.
• Act as a liaison between vendors, CMOs, and internal teams, maintaining clear communication to address production challenges, adjust schedules, and ensure timely delivery of components.
• Design, develop, and implement manufacturing fixtures and tooling to support efficient production and assembly processes.
• Conduct quality inspections and ensure compliance with cGMP and ISO-13485 standards, identifying areas for continuous improvement in production.
• Troubleshoot and resolve manufacturing and logistical issues, applying hands-on problem-solving skills to support seamless production flow and minimize disruptions.
  

Product Development Engineer Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Industrial, or a related field).
• 7 to 10 years of experience in medical device manufacturing, with a solid understanding of industry-specific standards and requirements.
• Strong project management skills, with experience managing production activities and coordinating with multiple stakeholders (e.g., CMOs, vendors).
• Proficiency in cGMP and ISO-13485 regulatory requirements and experience in implementing these standards in a manufacturing environment.
• Excellent communication skills, with the ability to collaborate effectively across internal and external teams.
• Hands-on experience with manufacturing fixture design, process setup, and troubleshooting on manual-assembly production lines.

Benefits

• Health and Dental insurance
• Paid Time Off (PTO) OR Vacation & Sick Time

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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.