Project Engineer
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 35 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.
Job Title: Project Engineer
Department: Engineering
Reporting To: Business Unit Engineering Manager
SUMMARY: Reporting to a Business Unit Engineering Manager, the Project Engineer will have an excellent understanding of engineering principles theories, concepts, practices and techniques. The Project Engineer will provide manufacturing support, implement process improvement initiatives and lead projects across a range of product lines
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Provide manufacturing support over a range of manufacturing processes
Lead process improvement initiatives to reduce cost and to improve manufacturing efficiency by using data analysis
Manage projects and lead new product introduction projects introducing new processes as appropriate
Carry out process and product validations
Implement product, process and material changes through validation, change control and documentation updates
Familiarize yourself with a variety of processes to allow you to work across a number of product lines
Conform to the requirements of the quality and environmental management system
Additional ad hoc duties and projects as assigned
QUALIFICATIONS AND EXPERIENCE REQUIRED:
Level 8 or equivalent Degree in Engineering or similar discipline is desirable
3 years’ experience in a medical device manufacturing engineering role is desirable
Knowledge of medical device validation protocols and associated documentation
Implementation experience of validation protocols
Knowledge of AutoCAD and Solid Works is desirable
Lean and six sigma knowledge
Strong process engineering background
New product introduction experience
Strong team player, with the ability to work on own initiative
Guided by the disciplines of due diligence and compliance in all aspects of work.
To be a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
Ability to work with cross-functional teams, including quality, production and supply chain.
Excellent interpersonal skills.
Ability to plan, organise, and prioritise own daily work routine to meet established schedule.
Good understanding of ISO 9001: 2008 and ISO 13485.
Excellent knowledge of MS Office