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Manufacturing Engineering Manager
Unilife Corporation - York, PA 17406
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Who we are:
Unilife is a U.S. based developer and manufacturer of state-of-the-art injectable drug delivery systems. We strive to create technologies that are best-in-class, in the wearable, disposable and customizable injector market. We win customers by out-innovating our competitors and delivering rapid, customer-centric, high quality solutions to drug delivery challenges.
Why Unilife:
Our culture is built on innovation, commitment to exceeding customer expectations, the pursuit of excellence, and an intrinsic desire to make drug delivery safer, easier and more efficient. By empowering our employees, we have created the most complete technology portfolio for injectable drugs on the market, backed by state-of-the-art facilities and a team with deep industry expertise. Our development cycle is fast and agile, allowing our employees to make an immediate and tangible impact. At Unilife, you will be surrounded by exceptional innovators, who thrive in a high-performance culture marked by fearlessness and hyper-productivity. Our hard working team has an unfaltering determination to excel in an intense start-up environment and a desire to gain tremendous personal and career growth.
Overview:
Unilife takes deep pride in its commitment to designing, developing, and manufacturing products that are changing the industry. Our Manufacturing Engineering Manager would be responsible for managing the manufacturing/process engineering and process development of our products in a controlled environment. They would ensure all processes are in compliance with SOP’s, current GMPs, and ISO standards.
Position Requirements :
- Manage the implementation of process development projects including new machine development, sample production, tooling development, design, prototyping, and testing.
- Ensure that engineering projects are run cost efficiently and deliver reliable processes and products.
- Effectively lead Engineers and Engineering Technicians to deliver goals and objectives
- Manage resource allocation and project management across multi disciplinary projects to ensure delivery of business objectives..
- Instill and maintain a sense of urgency and customer focus within the manufacturing engineering team. Act as voice of the customer.
- Explore and recommend changes to manufacturing systems based on analysis of modern, cost effective methods.
- Manage the transfer of technology to offsite subcontractors establishing qualification and validation of manufacturing processes within their facility. Will also generate cost estimates R.O.I. and comparative studies in determining the best fit for manufacture methodology.
- Support the management and justification of capital investment requirements for the site in line with business growth.
- Drive DFA/DFM process associated with existing and new products.
Qualifications:
- Bachelor’s degree in Engineering related field, advanced degree is preferred
- A minimum of 5 years overall engineering experience and minimum of 3 years experience managing engineers or other technical personnel.
- Experience new product introduction and in managing cross functional teams in an engineering/operational environment.
- Automation experience for low to medium volume production
- Ability to write, approve, direct and maintain process control procedures that describe the manufacturing process and controls necessary to ensure conformance
- Experience in a FDA regulated environment
- Medical Device Manufacturing experience
Job Type: Full-time
Required education:
Required experience:
- Engineering: 5 years
- Managing engineers or other technical personnel: 3 years
Indeed - 20 hours ago
