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Job Description

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Manufacturing Engineer

Region: Americas
Location: Wilmington, MA

Posted Date: 06/30/2022

Who We Are

Sirtex Medical is a fast-growing, dynamic global healthcare company with offices in Boston, Germany, Singapore, and Sydney, each aligned and working to improve patient outcomes in people living with cancer. Our current lead product utilizes a targeted radiation therapy for liver cancer called SIR-Spheres® Y-90 resin microspheres. To date, patients with liver cancer across more than 1,300 medical centers in over fifty countries have collectively received over 100,000 doses of SIR-Spheres® Y-90 resin microspheres. Our global Manufacturing Team is growing and we’re hiring a Manufacturing Engineer.  This position is located in our Wilmington MA manufacturing facility.

What You’ll Do

Reporting to the Global Head of Operations, the Manufacturing Engineer drives Engineering requirements within the Operations team as well as plays an active part in cross functional support, including Quality and R&D. You’ll drive design transfer activities related to any existing product, component or process changes impacting internal and external manufacturing.

Accountabilities would include many components, much of which are captured below. You will:

  • 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).

Who You’ll Be

To be successful in this role, we’ll require that you have:

  • Bachelor’s Degree in engineering or equivalent.
  • 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.
  • A sense of humor. We take our science seriously, just not ourselves.

Training Requirements:

  • Training in relevant Quality Systems and Regulatory processes as required
  • Training in Radiation safety as required
  • Training in the Distribution and handling of radioactive materials (IATA)
  • Training on Lean-Six Sigma methodologies.

What To Expect at Sirtex

If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate:

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity, and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through career development and training opportunities
  • Challenging work to continue to develop new and better ways to improve clinical outcomes for oncology treatment around the world

Compensation and Benefits 

Sirtex Medical has been named a best-in-class employer in the United States after scoring in the top quartile of large and midsize employers who participated in Gallagher’s 2021 Benefits Strategy & Benchmarking Survey. Sirtex was recognized as an organization that provides innovative solutions for creating organizational structures, workplace policies and total rewards, which inclusively engage and motivate its employees.

Gallagher’s Best-in-Class awards recognize employers that excel in supporting their employees’ physical, emotional, career and financial wellbeing for better organizational outcomes. “The HR team and I are passionate about creating a culture that cares about you and your family’s wellbeing,” said Sirtex Chief Human Resources Officer Cathleen Lowndes. “Our benefit program in the US is special and something I think we can all be proud of. While we still have opportunities to continue investing, we have made a number of noteworthy upgrades in the past few years.”

Recent upgrades to U.S. Benefits at Sirtex include:

  • Implemented Flexible Work Policy 
  • Added domestic partner benefits
  • Provide adoption assistance resources
  • Upgraded our EAP program to provide you more mental health/wellness options
  • Purchased a la carte hearing benefit
  • Evolved our leave policies to be inclusive 
  • Added an additional medical plan to lower medical premium costs passed on to you
  • Launched Own Your Career – $4000/per employee for professional development

“We take a proactive and structured approach to planning, developing and implementing comprehensive benefits and HR programs,” explained Cathleen. “We believe supporting our workforce builds our overall organizational strength and resilience. Without a doubt – we know that our people are the most important asset of Sirtex. “

Conditions of Employment

  • Sirtex Medical has implemented a mandatory vaccination policy effective November 1, 2021, requiring the COVID 19 vaccination for all employees. In accordance with Sirtex’s duty to provide and maintain a workplace that is free of known hazards, we are adopting this policy to safeguard the health of our employees and their families, and the community at large from infectious diseases that may be reduced by vaccinations. Individuals seeking an exemption from this requirement for medical or religious reasons should complete a request for accommodation form and submit the form to the human resources department.
  • Physical requirements include sitting, walking, standing for prolonged periods, possible radiation exposure.
  • Willingness to:

-Participate in all relevant formal training events

-Observe and comply with all Sirtex corporate policies

-Work within, and ensure adherence to quality system procedures, work instructions, and other quality systems

-Work within, and ensure adherence to health, safety, and environmental management system procedures, instructions, and other necessary factors.

Sirtex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.                                                                                                   

Apply Now!  

Be part of an amazing team that is helping to save lives, every day.