Research Manager jobs in Goshen, KY

Overview

The key person in this position will work to design, organize and systematize the manufacturing activities for rapid prototyping, regulatory approval and small to medium scale medical device production in a dynamic and rapidly evolving hand-assembly manufacturing environment.

Responsibilities & Activities

• Evaluates and revises existing manufacturing processes and personnel, rapidly adapting to evolving production levels
• Develops manufacturing processes able to pivot to accommodate highly variable volume and new device development projects
• Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout and manpower requirements
• Reviews development plans for compliance with accepted engineering standards and good engineering practices
• Provides quality assurance for product and process
• Manages production, labor, and material costs.
• Education Requirements and Related Experience and skills
• BSME or four-year technical degree or equivalent combination of education, training, and experience MBA, or MEM or equivalent combination of education, training and experience
• Strong medical device or electronics manufacturing experience required
• Minimum of 3-5 years manufacturing or engineering experience
• Expert experience using CAD, CAM or other design software
• Basic understanding of controls technology and associated regulations
• Exceptional organizational skills
• Strong analytical skills.
• Desired Skills:
• Knowledge of mechanical systems and control systems
• Knowledge of Medical Device regulatory requirements and processes
• Understanding of technical files
• FMEA analysis preferably COSMOS.

Job Type: Full-time

Pay: $73,468.33 - $88,477.98 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Experience:

• medical device or electronics manufacturing: 5 years (Preferred)
• regulatory compliance (IEC 60601, 21 CFR part 800-889: 4 years (Preferred)
• FDA 510(k) submission: 3 years (Preferred)

Work Location: In person