Sirtex Medical is a global healthcare business with offices in Boston, Sydney, Germany, and
Singapore, working to improve outcomes in people with cancer. Our current lead product is a
targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300medical centers in over 50 countries.

At Sirtex, we’re transforming our industry through our leadership with interventional oncology
and being a values-led company. To do this, we empower our people to realize their potential
through life-changing work. We offer stimulating careers and development, encourage
innovation, and strive for excellence in everything we do. We will always foster a diverse and
inclusive workplace, in which our global teams are united by an unwavering commitment to
improve the quality and longevity of patients’ lives by providing innovative interventional
oncology solutions.

Here, you will be a vital contributor to our inspiring and bold mission.Job Description

The Manufacturing Engineer drives engineering requirements within the manufacturing environment of Sirtex facilities. This role plays an active part leading process validation with cross functional teams, including but not limited to Quality, RA, Ops, Engineering and R&D. This position drive design transfer activities related to any existing product, component or process changes impacting internal and external manufacturing.

• Assist with the set-up of new Manufacturing Processes or improvement of existing ones.
• Manage the successful scale up and commercialization of this new processes ensuring that target yield, capacity, throughput time and productivity are achieved.
• Assist with the design, procurement and construction “Lean” production lines considering flow optimization, throughput time, product movement, layout, and space.
• Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on site Factory Acceptance Testing of equipment.
• Set up Preventive Maintenance and Calibration routines.
• Lead the knowledge transfer of new manufacturing processes and provide training to product builders and technicians.
• Provide ongoing day to day support to Production; continually seek to drive improvement in operation performance while also maintaining highest levels of regulatory conformance.
• Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs.
• Set up and order Product, Components, Consumables, and Material necessary for validation and production.
• Draft IQ/OQ/PQ protocols. Develop and execute required validations in line with regulatory requirements to include Equipment, Process & Product validations.
• Drive FAT (Factory Acceptance Test) for Mfg equipment necessary for internal/external Mfg process in which Sirtex own the product/process design.
• Partner with R&D, Quality and Operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective
• Analyze product designs for best method of manufacture
• Direct the design, development, and/or improvement of manufacturing processes
• Coordinate input from internal/external customers to better understand customer needs and/or perceptions
• Keep abreast of current product developments and trends in areas of expertise
• Support the purchase and installation of new equipment associated within manufacturing
• Direct the development and/or improvements of manufacturing processes and equipment
• Evaluate expenditures for processes and/or equipment.
• Ensure lessons learned are analyzed and documented.
• Ensure that manufacturing has accurate and detailed information on specifications
• Analyze product designs for best method of manufacture
• Propose and evaluates the processes for equipment in assigned area
• Direct the design, development, and/or improvement of manufacturing processes
• Coordinates input from internal/external customers to better understand customer needs and/or perceptions
• Monitor, Control and Optimize budget for Product/Process Internal/External Manufacturers.

Lead Operations projects to improve cost, quality, and performance of post market products throughout cross functional teams such as Design Assurance, Regulatory Affairs, Legal, Clinical Affairs, Marketing and Sales ensuring the timing and effective development, planning and implementation of product/process design changes, with Quality and Design for Manufacturing (DFM).Qualifications

• Bachelor’s Degree or equivalent experience
• 3 years’ experience in a similar role.
• Strong technical understanding of set up and maintenance of manufacturing processes, experience in validation, equipment design
• Strong problem-solving capabilities through tools and techniques to implement systematic solutions internal/external processes.
• Execution focused, able to move from hands on tasks to providing guidance to the team and in turn enable it to achieve success
• Thorough knowledge of the current quality and regulatory requirements for medical devices required; knowledge of isotopes/radiation desired
• Experience in construction and build out of operations facilities
• Desirable experience working with Radioactive materials
• Ability to build strong networks within the organization, influence, gain buy in, and implement change at all levels, cross functionally
• Ability for overseas and domestic travel – 20%
• Ability to work off hours as dictated by global requirements
• Results oriented characteristics with a continuous improvement mindset.
• Ability to work in a fast-paced and rapidly changing environment with competing deadlines.
• Ability to learn and adapt quickly to changes to comply to systems, policies, and procedures.
• Collaborative, team player, ability to pivot to project demands, prioritize and multi-task.