AddressSr. Medical Device Engineer
About the Organization Harmac Medical Products, Inc, based in Buffalo, N.Y. is a leading, award-winning contract manufacturer of single-use Medical Devices, serving the global marketplace for more than 40 years. With manufacturing locations in the U.S., Ireland and Mexico, the privately held company provides innovative technical solutions and manufacturing services for leading Fortune 500 med-tech companies and high potential start-ups. Harmac's mission is to change the lives of patients, employees and the communities in which we work.
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.
Category Engineering
Full-Time/Part-Time Full-Time
Shift First
Number of Openings 1
Salary Range Starting Salary: $87-97K
Description
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.
Impact
Ensure cost expectation levels are met and maintained
Recommend, design, develop manufacturing process/procedure improvements
Analyze potential areas for savings or efficiencies using 6 Sigma and lean manufacturing methods.
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
Starting Salary: $87-97K
Position Requirements
Analysis/Problem Solving
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.
Communication
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, quality assurance teams, regulatory authorities, clients, customers, and the public.
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)
This position is currently accepting applications.
