Job Summary

Plans, designs, and develops production and manufacturing processes of single-use medical devices according to customer specifications and in accordance with company standard operating procedures by performing the following job duties.

Job Duties

• Leads Customer Projects and works directly with the Customer on schedule, qualifications, and all aspects of the project from start through validation to commercial sales. This involves creating project plans, setting timelines, allocating resources, coordinating activities, and ensuring successful execution of medical device development projects.
• Coordinates development and startup activities with internal departments and customers. Creates, manages, and maintains project schedules to meet internal and customer deadlines.
• Reviews customer specifications and needs. Translates this data into product engineering specifications and manufacturing processes to establish efficient production rates and reliability of finished products.
• Ensures compliance with regulatory standards and regulations such as FDA requirements, ISO standards, and other regional or international guidelines
• Identifies materials, conceptualizes processes, designs tooling, and determines labor content to successfully meet customer’s expectations on volume, cost, and quality.
• Prepares prints, bills of material, process documentation, and other engineering documents. Oversees product testing validation to ensure compliance with safety, performance, and quality requirements.
• Oversees, coordinates, and performs design verification and validation activities to include Part Process Performance Qualifications.
• Designs, develops, qualifies, and validates manufacturing tooling, automation, equipment, and processes in accordance with company standard operating procedures. May develop and releases test fixtures/assembly aides for use in manufacturing.
• Maintains engineering documents to reflect changes in customer, vendor, or internal specifications.
• Remains alert to new technologies (including process, materials, and equipment), industry trends, and regulatory changes which can improve cost margins, manufacturability, safety, throughput, and yields.
• Assists sales department in estimating materials, labor, and tooling for preparation of quotations.
• Mentors new Product Engineers.
• Demonstrates Harmac’s core values of honesty, integrity, and respect.
• Other duties as assigned.

Why work at Harmac?

Harmac provides our employees with more than just a great place to work. Our comprehensive benefits package, employee wellness program, and a suite of perks help our people to get the most out of their workplace experience.

Harmac offers the following perks and benefits to all employees:

• Health, Dental, and Vision insurance
• 401K
• Paid holidays and vacations
• Tuition reimbursement program
• Quarterly bonuses
• Peer recognition initiatives
• Summer scholarships for children and grandchildren of employees
• On-site gym
• Employee of the Month program
• Onsite social worker to assist with important life events

Skills/Technical Skills

• Communication and Teamwork Skills
• Computer skills required, including Microsoft Office Applications, Lotus Notes, Graphic applications, E-mail, and other related task-specific software.
• Engineering design software such as Solidworks; understanding of design intent and the ability to understand which features of the print can and cannot be changed in order to retain the original intent
• Lean Manufacturing / 6 Sigma / Black belt
• Injection Molding, Ultrasonic welding and/or Radio Frequency welding

Knowledge

• Understands regulated type industries – FDA, FAA, ISO 13485, Automotive
• Knowledge of medical device manufacturers and supplies knowledge preferred
• World-class manufacturing knowledge preferred

Education

• Bachelor’s degree in Mechanical, Plastics, Biomechanics, or Biomedical Engineering from a four-year college or university

Experience

• 4 years of related experience after graduation and/or training
• Lean Manufacturing / 6 Sigma / Black belt
• Working in a regulated environment, such as FDA, FAA, or Automotive
• Production Line layout
• Understanding of process FMEAs and process Validations (IQ, QQ, PQ)