Position Summary: Responsible to manage a regulatory team to oversee all aspects of the pre-market or post-market regulatory activities required to maintain compliance to US FDA, Health Canada, European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746, MDSAP country regulations, as well as other country regulatory agencies.  Provides regulatory leadership to the Company reporting to executive management on the status of pre- and post-market projects. - Post-market RA...

Job Summary This position is responsible for product development and design transfer activities for new products from R&D to Manufacturing. The position requires utilization of both technical knowledge and lean concepts to manage the overall new product introduction activities ensuring that the resulting finished products meet all required safety, quality, and manufacturability by a process of robust design control that includes both product/process development and process validation activities. As Product Transfer & Packaging Design Manager, this position is responsible...

Position Summary: Responsible for leading the process engineering and production support of a product or product line.  Provides technical leadership and support for continuous improvement team efforts focused on process improvement and optimization.  Provides engineering leadership for the design, documentation and implementation of assembly methods, test methods, equipment operation, including specification and optimization.

The Packaging Technician is primarily responsible for labeling components, pouching plates and beads, pulling QC samples, and assembling kits for sale. This role is also responsible for label control and accountability, as well as labeling vials and keeping inventory of reagent components, boxes, and inserts. As a Packaging Technician you will be responsible for pulling the correct lot numbers and the correct quantity of kit reagents for final product QC testing or sales requests. This includes setting up kit assemblies, completing kit assemblies, and providing maintenance to and cleaning of equipment assigned to Packaging Department.  If you’ve...

We are seeking a Medical Technologist to join our Quality Laboratory team. The Medical Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Werfen products according to approved Standard Operating Procedures (SOP’s) within defined timeframes. As a Medical Technologist, you will perform all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. blood borne pathogens and chemical hazards). You will assist the department supervisor and/or manager with...

Position Summary:   Under general supervision, this position supports the production of medical devices. Duties include a variety of technical support and administrative duties related to complex electro-mechanical test equipment and hand fixtures. Duties are performed within a cGMP/regulated environment with proper documentation of work performed

We are seeking a results-driven Buyer/Planner who will be responsible for monitoring, managing, planning, and purchasing Raw Materials to support the following: - a fast paced FDA regulated manufacturing environment - to meet working capital, inventory, and other financial targets - to meet Kanban requirements - to fully support qualifications/validations -

We are seeking to hire an individual with a background in medical diagnostics and ideally blood banking to serve as our Field Service Technician. As Field Service Engineer, you will be providing corrective maintenance, installation and calibration of equipment at the customer sites. You will also be providing a high level of responsiveness to customer issues. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

We are seeking to hire an individual with a background in medical diagnostics and ideally blood banking to serve as our Field Service Technician. As Field Service Engineer, you will be providing corrective maintenance, installation and calibration of equipment at the customer sites. You will also be providing a high level of responsiveness to customer issues. If you’ve got the necessary skills and experience to excel in this position, we want to hear from you. Apply today!

Responsible for manufacturing operations for the Warren site. Provides day to day leadership and management of production, manufacturing improvements, and execution of sitewide operational excellence initiatives. Works to improve quality and ensure products ship on time. Site champion of Werfen Values, exemplifying a culture of teamwork and collaboration. Also responsible for new product transfer from R&D, including process design and process transfer. Partners with Quality counterpart to ensure both site and customer quality goals are met.

We are seeking a Blood Bank Technical Specialist to join our team of professionals at Werfen to cover (ADD Territory). This person will support the implementation of specified product lines and deliver ongoing field support for instrumentation and reagents after installation and go-live.   Secondary ownership of assigned customer targets within geographic territory.  Achievement of annual instrument go-live and reagent sales objectives in all targeted Werfen markets.  Lead the stages of the Sales Lifecycle associated with instrument go-live and customer complaint handling within assigned customer base.  Provide training and technical support in the field for...

We are seeking a Development Scientist for our Research & Development group. The Development Scientist performs a variety of tasks associated with the development of new products and manufacturing processes, the investigation into and implementation of product and process changes, and the transfer of new products and processes to the manufacturing departments. If your degree is in medical technology, biology, or immunology, this is a great opportunity to launch your career in assay development! This position is not eligible for sponsorship for...

Position Summary: This position is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products.  The position independently develops, applies, and implements methods, tools and practices to achieve product quality goals and requirements in the areas of design, development, production, distribution, maintenance and service.  

Position Summary: The Senior Staff

Position Summary: As a member of a commodity team, responsible for providing leadership, insight, guidance, and problem solving skills to all technical issues encountered by the team in the sourcing, manufacturing, and cost reduction activities of the assigned purchased or outsourced products/services.

Position Summary: The Tax Manager will support the Werfen US Tax team’s federal, state, and international income tax accounting, compliance, and planning functions. The Tax Manager will complete monthly tax provisions and reconcile tax accounts on a timely basis in accordance with Werfen’s monthly close process. The Tax Manager will work crossfunctionally within Werfen to document tax positions. The Tax Manager will maintain workpapers to support tax information presented on the US group’s federal, state and Canadian income tax returns. The Tax Manager...

Overview:   The purpose of this internship is to provide an Intern with direct experience and understanding related to the technology and medical application of electrochemical sensors.  This work will provide support for characterization and large-scale testing of electrochemical sensors as a component of developing clinical instrumentation.   Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need.  Ideal candidates will combine technical knowledge with analytical...

Position Summary: The Chemist is responsible for applying knowledge and skill in support of chemical formulation and analysis of production blends, and for testing incoming raw material component products. This is a temp to hire posititon with the inital contract being 3 months.   The pay range for this position is currently $28-$38/hr. Individual compensation is based on the candidate’s qualifications for the position, including...

Position Summary: Under minimal supervision, leads software development activities including software requirements, architecture, design, implementation, and integration.

Overview:   The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance.  Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need.  Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities.