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Senior Sustaining Engineer
Location: Woburn MA
Advertising Date: Fri 05 November 2021
Sirtex Medical is a global life sciences company with offices in the US, Australia, Germany and Singapore, working to improve outcomes in people with cancer. Our current lead product is a targeted radiation therapy for liver tumors called SIR-Spheres® Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 50 countries.
The Sustaining Engineer will
- Provide engineering support to design and/or process alterations to existing products.
- Manage engineering activity required to support products through the commercialized life cycle.
- Manage and execute engineering requirements for commercial product.
- Lead introduction of new products into production phase.
- Potential supervision of engineering technicians and interns.
This is an on-site position based in the Woburn MA office and the employee will be required to work in the office on a regular basis.
- Coordinate Design Change and Process Change activities for the assigned product lines
- Assess proposed Design and Process Changes for the impact to the organization; create project proposals
- Interface with vendors to support existing and new manufacturing process throughout the product life cycle.
- Develop and document design inputs, design outputs and engineering specifications for devices, components and materials for changes to existing products
- Ensure design change activities, processes and practices are in compliance with internal quality system and design control requirements.
- Maintain and supplement design history files for existing product
- Assist in R&D efforts as needed for new product development or research initiatives
- Develop test methods, create written procedures and perform product testing
- Design, execute, analyze and document engineering experiments to guide product and process development
- Provide engineering support for verification, qualification, and validation studies on existing products and new products within the manufacturing transfer process
- Provide engineering support for risk management activities and risk management reviews on existing products
- Provide engineering support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
- Provide engineering support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
- Oversee and contribute to cross functional project teams for new product onload and updates to existing products
- Create and manage timelines for product updates from concept through manufacturing transfer, or interface closely with Project Managers in support of this effort.
- Proactively communicate program progress, risks and recommendations to management as appropriate
- Support regulatory approvals and responses to regulatory questions for existing products.
- Operate within Sirtex procedures and industry standards for product development and manufacture
- Maintain laboratory notebooks to document work activities
- Attend clinical activities including observing medical procedures and interfacing with clinicians
- Participate in animal studies related to engineering assignments
- Participate in patent related activities related to engineering assignments
- Mentor, train and supervise engineering technician or intern
- In addition to the essential functions listed above, other responsibilities related to Sirtex product engineering activities as assigned
- Potential for supervision of engineering technician or intern.
Educational Prerequisites and Skill requirements
- BS degree in engineering (Biomedical, plastics, mechanical or similar)
- Minimum of 8 years of hands-on experience in medical device manufacturing and development
- Experience in a multinational medical device company providing exposure to mature design control, quality management and manufacturing systems
- Experience with primary project ownership while contributing to multiple parallel projects
- Experience with manufacture, development or testing of disposable medical devices, and preferably some durable devices
- Experience generating, modifying and maintaining engineering documentation packages and design control deliverables
- Experience with primary and secondary processes commonly used in medical device fabrication, including injection molding, extrusion, melt and adhesive bonding and machining
- Experience with medical radioactive isotopes a plus.
- CAD experience (preferably SolidWorks)
- Good mechanical aptitude
- Practical understanding of materials properties, stress/strain, kinematics/dynamics and various fabrication processes and technologies
- Experience with polymeric materials and metals with good understanding of their properties
- Ability and personality to manage projects in a fast-paced environment
- Understanding of design controls, risk management and regulatory requirements associated with medical technologies
- Must have working knowledge of ISO 13485 and FDA Quality System Regulations
- Team player possessing a high level of ethics and professional integrity
- Ability to produce prototypes and test units in an engineering lab environment
- Excellent verbal & written communication skills applied within the company and with vendors and consultants
- Ability to work with outside entities (engineering support, vendors, test houses, academic institutions) applying strong organizational and communication skills.
- Must be able to work independently and be self-motivated
Physical Demands and Conditions Requirements
- General office and engineering lab environment
- General office equipment.
- Hand tools and light machine tools
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.
What You Can Expect from 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.
To apply, please email your cover letter and resume to Human Resources at email@example.com
Sirtex is an Equal Opportunity/Affirmative Action Employer including Disabled/Vets