List of Current Positions
Senior Product Development Engineer
We have built a team of industry-leading innovators who are committed to developing life-enhancing drug delivery products. Our product development engineers design, develop, and validate new medical device products. We hire perpetually curious problem solvers who are committed to making drug delivery safer and more effective, and who excel in our fast and agile development environment. We continuously seek to add driven product development engineers looking to make an immediate impact in a highly dynamic organization to our team.
- Support all phases of new product design and development to product design finalization and commercialization.
- Design and develop new medical device products and product improvements, and customize products to customer needs and expectations.
- Support new product scale-up, process optimization, technology transfer and process validation activities and support manufacturing engineers in ensuring products are designed for manufacturability and that assembly and testing processes and designs are compatible for new product technology transfer and establish future process and manufacturing technology.
- Assist with the design and selection of tooling and production equipment for assigned projects.
- Create accurate and complete records of product development activities and team deliverables in compliance with the documentation requirements of Unilife’s Quality Management System and record the creation of new intellectual property and support patent applications and filings, as well as invention disclosure reports.
Education & Experience:
- A bachelor’s degree in aerospace, biomedical, chemical, electrical, manufacturing, mechanical or a related engineering field is required; advanced degrees and mechanical engineering degrees are preferred.
- A minimum of 5 years of mechanical design experience is required. Experience with plastic-injection molded parts and glass and metal components is preferred, as is experience within the pharmaceutical and/or medical device industry in the development of medical devices or combination products.
- Advanced experience in the development of new medical device products from design to manufacture and experience in the design of drug delivery systems is preferred.
- Experience and skill in applying and transferring new product knowledge to manufacturing, and knowledge of medical device manufacturing processes, and product prototyping, testing and planning is required. In-depth knowledge of applicable FDA and ISO requirements for medical device design and manufacture and experience working within ISO quality systems is required.
- Experience working successfully in a multi-skilled environment and possession of cross-disciplinary skills or the ability to grasp requisite skills outside of core skill-set is preferred.
- Must be confident and capable in a customer-facing role, demonstrate proactive and strategic thinking and be able to handle change and ambiguity.
- Advanced reporting, technical writing and computing skills are required.
- Must be proficient in the use of SolidWorks and Auto-CAD, as well as Microsoft Office applications.
Our Supply Chain team ensures that our product development engineers and customers have access to the highest quality products at the greatest value. The Materials Manager will be responsible for managing diverse supplier relationships and continuously improving the company’s value stream efficiencies.
- Manage the preparation and execution of inventory plans for raw material, work in process and finished goods to minimize inventory and meet customer delivery and quality requirements.
- Manage suppliers through establishing, maintaining and cultivating long term relationships.
- Place purchase orders, follow up, expedite, and perform issue resolution.
- Perform material planning for assigned commodities, parts, and materials, within and outside of the company's ERP system.
- Oversee effective use of the SAP system to achieve cost, inventory, and customer service objectives.
- Coordinate implementation of engineering changes to components and finished products to ensure adequate flow of materials without incurring obsolescence.
- Contribute to the achievement of total customer satisfaction by providing high quality and timely service to all internal and external customers.
- Oversee demand management by balancing customer order schedules and forecasts with available capacity and material.
- Assist with the selection of and oversee the ongoing performance of all suppliers.
Education & Experience:
- A bachelor's degree in supply chain management, engineering or other related technical field is required. Extensive on the job skills development and experience may substitute for a bachelor’s degree.
- A minimum of 5 years of experience in Supply Chain (Materials Management, Buyer/Planner, Procurement, etc.) in both product development and manufacturing in a GMP or other regulated environment is required.
- Experience with SAP is preferred.
- Must have demonstrated business acumen and excellent communication and interpersonal skills.
- Must be a hands-on manager with the ability to work individually and as part of a team.
The Project Manager supports the overall planning, direction, and timely execution of several project segments. The ideal candidate will have prior experience in a project manager role, and have strong documentation, organization, administration, and communication skills.
- Attend project meetings, take meeting minutes and follow up on action items.
- Maintain a high level of project planning and organization to ensure adherence to aggressive timelines and to exceed customer expectations.
- Provide logistical support, coordinate and set up meetings, events, off sites, etc. Manage the entire process by arranging locations and necessary equipment, preparing agenda and relevant information, taking minutes and other relevant tasks.
- Track and follow up on urgent and pending issues.
- Create clear, milestone-based project plans to achieve project goals on schedule.
Education & Experience:
- A bachelor's Degree in an engineering or related field is required; advanced degrees are preferred.
- A minimum of 3 years of professional work experience in program/project management is required.
- Must have strong written and communication skills, experience creating PowerPoint presentations with meticulous attention to detail, and demonstrated high level of initiative and ability to work in a fast paced, fluid environment.
- Must be deadline driven and desire to make an impact in an organization dedicated to changing the future within the medical device industry.
Senior Quality Assurance Engineer
Unilife’s world-class team is committed to developing and supplying medical devices to the highest standards for quality. Our Senior Quality Assurance Engineers ensure that our products, production processes, environment, and practices are in compliance with applicable FDA regulations, ISO standards, customer expectations, and standard operating procedures. We continuously seek to add driven Quality Engineers to our team – including experienced industry leaders – who are looking to make an impact in a highly dynamic organization.
- Develop, apply, revise and maintain quality assurance protocols and methods for processing components into partially finished or finished products.
- Plan, implement and manage compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.
- Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
- Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Assure product development and production compliance to cGMPs, ISO standards, FDA regulations and customer expectations.
- Support manager with regulated body and customer audits.
- Good Team Player: Support manager by reacting to change productively, accepting additional assignments positively and controlling rumors or negative comments or behaviors. Act as a positive example to workforce and as an advocate for cGMP, ISO standard and FDA regulatory compliance.
Education & Experience:
- A bachelor’s degree in biomedical, chemical, electrical or mechanical engineering is required.
- Advanced degrees, mechanical engineering degrees and certification as a Certified Quality Engineer are preferred.
- A minimum of 5 years of experience as a quality assurance engineer in a medical device or pharmaceutical manufacturing environment is required, as well as significant experience with validation, CAPA, risk analyses, and nonconformance investigations.
- Must understand important trends, have knowledge of transfer to manufacturing, manufacturing processes, medical device regulations, testing, and planning.
- Must have strong interpersonal and communications skills, and pragmatic and creative problem-solving and analytical skills.
Unilife’s world-class team is committed to developing and supplying medical devices to the highest standards for quality. Our Quality Engineers ensure that our products, production processes, environment, and practices are in compliance with applicable FDA regulations, ISO standards, customer expectations, and standard operating procedures. We continuously seek to add driven Quality Engineers to our team – including experienced industry leaders – who are looking to make an impact in a highly dynamic organization.
- Participate in the development of quality plans and supporting documents for new medical device products, including preparing for notified body/FDA audits.
- Develop inspection programs and methods for new components, assemblies and finished products, and instruct quality control technicians on test methods and documentation.
- Provide quality engineering support to medical device manufacturing, and develop and approve test method validations, verification and validation strategies,and related activities, protocols, and reports.
- Use statistical tools (Minitab, etc.) to analyze data, make acceptance decisions, and improve process capability.
Education & Experience:
- A bachelor’s degree in biomedical, chemical, mechanical or a related engineering field is required; advanced degrees are preferred.
- A minimum of 2 years of experience as a quality engineer in a medical device or pharmaceutical manufacturing environment or related industry is required.
- Experience with FMEA & Risk Management, process validation protocols and reports (IQ/OQ/PQ), and experience and skill in performing risk analysis, root cause analysis; developing a corrective action plan, and implementing the plan is required.
- Must know how to implement applicable FDA regulations and ISO standards, including 21 CFR 820 and ISO 13485.
- Must have the ability to deal with ambiguity and drive for results; must be detail orientated and have change implementation skills.
Embedded Software Engineer
The Embedded Software Engineer is responsible for software architecture, and the design, development, and verification and validation (V&V) of software associated with innovative drug delivery medical devices. The ideal candidate would have an understanding of embedded software development, C/C++ and hardware (HW)/software (SW) interfacing. The Embedded Software Engineer will develop and maintain software for prototype and production devices, and conduct technical experiments on new products to prove technical feasibility. The Embedded Software Engineer will prepare and maintain formal documentation and ensure compliance with company procedures.
- Design and implement robust, embedded device software solutions in C/C++ for new drug delivery products.
- Manage project-planning relating to all aspects of software engineering activities to achieve project milestones and goals.
- Interact with cross-functional teams (mechanical and electrical engineers, quality and regulatory staff, and manufacturing operations) to ensure that new products meet customer expectations and support the design, development, testing and production activities of cross-functional teams.
- Apply advanced technical principles to complex problems to create innovative solutions.
- Recommend new software tools, including compilers/linkers, debuggers, and SW analyzers, and identify associated lab equipment to support product development.
Education & Experience:
- A bachelor’s degree in computer science, computer engineering or a related field, or equivalent work experience is required.
- Must have excellent coding skills in C/C++.
- Working knowledge of IEC 62304 software process and IEC 60601 medical device design regulations, or equivalent in another regulated industry is required.
- Experience developing test framework solutions, writing formal software documentation and conducting V&V for medical devices, or for another regulated industry is required.
- Demonstrated success in embedded software design, prototyping, development, and troubleshooting is required.
- Must have excellent written and oral communication and interpersonal skills and current work authorization.
At Unilife, we are continuously growing to meet the needs of our customers. We provide flexibility on work location for many of our positions. For positions that may be performed from our York headquarters and manufacturing facility or our Unilife Innovation Center outside Philadelphia, we may provide some flexibility on work location. To maintain team cohesion, team members regularly travel between and work from both locations. Learn More.
While some openings are for one employee to fill one position with Unilife, we conduct ongoing recruitment for many of our openings and continuously hire to fill these positions. We also recruit for all levels of talent at the same time. For example, when recruiting for engineers, we are open to candidates who are recent graduates, as well as engineers who have achieved the status of senior principal engineers. We also provide internship and cooperative education opportunities for gifted engineering students. Please contact us or submit your resume.