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At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others.
Essential Duties
Position Overview
The Manufacturing Engineer will work cross-functionally to lead and provide engineering expertise on a variety of Manufacturing Sciences activities within Operations. This role will lead or support the design and development of new manufacturing processes/capabilities for reagent and collection kits and other automation projects as part of the design transfer process. This role will support Supply Chain and other internal functions providing technical expertise with external Contract Manufacturing Operation (CMOs) to drive continuous improvement efforts and ensure product quality that meets internal specifications.
Essential Duties
Include, but are not limited to, the following:
- Lead large and complex technical projects and cross functional initiatives with minimal guidance from leadership.
- Serve as the technical expert on assigned projects, providing engineering support and direction to project managers.
- Conceive, specify, procure, and implement engineering controls installation and modifications to support new manufacturing solutions, volume growth, and new product introduction with input from key internal and external stakeholders.
- Identify and develop a high-level implementation plan for, and execute projects associated with process efficiencies/cost savings opportunities in Operations.
- Provide technical engineering expertise for the design, development, and testing of new reagent and collection kit components and packaging solutions.
- Assist in consolidation of generated project data for interface with functional specialist on cross-functional teams, to ensure stakeholder understanding of trade-offs amongst cost, schedule, quality, and risk.
- Develop and maintain documentation (standard operating procedures, user requirements, design specifications, component specifications and selection, commissioning protocols, etc.) necessary to ensure consistent, high-quality projects.
- Lead or participate in investigations and troubleshooting of manufacturing processes associated with internal review, CAPA, audits, or complaints.
- Strong documentation skills and attention to detail necessary in a GMP environment.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability and means to travel 10% between Exact Sciences locations may include overnight/weekend travel.
Minimum Qualifications
- Master’s degree in Chemical, Mechanical, or Industrial Engineering or a field related to the essential duties of this role and 4 years of related experience; or Bachelor’s degree in Chemical, Mechanical, or Industrial Engineering or a field related to the essential duties of this role and 6 years of related experience.
- Experience with line assembly processing of materials and injection molding.
- Experience with contract manufacturing.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
Preferred Qualifications
- Experience working in a cGMP / ISO 13485 compliant manufacturing environment.
- Experience with equipment procurement.
- Experience with managing cross functional / multi-sites project.
- PMP certification.
- 3+ years of experience executing projects using continuous improvement approaches such as LEAN Six Sigma and/or Practical Process Improvement (PPI).
- Demonstrated ability to identify opportunities for improvement, reduce ambiguity by clearly defining project scope, and successfully complete projects with increasing complexity and size.
- Demonstrated ability to effectively plan projects, balance multiple competing priority projects, and lead medium to large scale projects to successful completion through disciplined project management methodology and tools.
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Salary Range:
$91,000.00 - $155,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.
