25 Senior Product Development Systems Engineer Jobs in Cambridge, MA
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Senior Product Development Systems Engineer
$117k-142k (estimate)
Full Time | Scientific Services
6 Days Ago
Exact Sciences is Hiring a Senior Product Development Systems Engineer Near Cambridge, MA
Help us change livesAt 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.
Position OverviewThe Senior Product Development Systems Engineer is a key problem solver and a potential team leader to lead cross-functional workstreams and plan product development activities for projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities.
Essential DutiesInclude, but are not limited to, the following:
$119,000.00 - $190,000.00
The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.
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.
Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company’s affirmative action program.
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.
Position OverviewThe Senior Product Development Systems Engineer is a key problem solver and a potential team leader to lead cross-functional workstreams and plan product development activities for projects for In Vitro Diagnostics (IVD) medical devices from concept to manufacturing. This position will use expert technical skills, conceive, plan and lead R&D product development activities to achieve project goals. This position will leverage understanding of advanced engineering principles, advanced engineering methods, data, and judgment to influence the course of product development activities.
Essential DutiesInclude, but are not limited to, the following:
- Apply technical expertise to lead or support efforts in planning and executing system-level product development activities for medical device/systems.
- Assess design feasibility and product functionality from a system-level perspective and/or confirm product capabilities.
- Participate in new product design and design improvements to existing products.
- Participate in the evaluation and assessment of competitive products, processes, and/or new trends.
- Engage with the Original Equipment Manufacturer (OEM)to provide technical oversight and guidance on evolution of the design.
- Collaborate with hardware, software, and reagent development scientists to interpret and decompose voice of customer, user needs, and/or customer requirements.
- Participate in the definition and creation of system architectures and documentation trees.
- Responsible for requirements management activities involving creation, decomposition, and traceability of requirements.
- Lead system integration activities during product design and Verification and Validation (V&V) phases.
- Lead the effort to ensure the necessary documentation for V&V activities are included in the project Design History File (DHF).
- Collaborate with cross-functional teams to ensure all development activities are conducted in adherence to applicable national/international regulations, guidelines, company policies, SOPs, and industry standards.
- Support Human Factors Engineering/Usability Engineering tasks and activities.
- Support product risk management activities involving system Hazard Analysis (HA) Failure Modes and Effects Analysis (FMEA).
- Collaborate with Quality team to establish templates and processes for the documentation of systems engineering tasks and activities.
- Participate in the definition of key development deliverables, milestones, dependencies, risks, and mitigations as part of the Integrated Program Plan.
- Establishes interfaces across other organizational groups.
- Strong analytical and problem-solving skills.
- 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.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work nights and/or weekends.
- Ability to lift up to 25 pounds for approximately 5% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability and means to travel between local Exact Sciences locations.
- Ability to travel 15% of working time away from work location, may include overnight/weekend travel.
- Bachelor's degree in Engineering, or field as outlined in the essential duties.
- 8 years of relevant experience as a product development engineer.
- 6 years of experience with requirements development from user needs, design transfer functions, and risk management.
- 6 years of experience working on projects with cross-functional technical teams through a formal phase gate or new product development process.
- 4 years of experience with ISO requirements and GMP guidelines, FDA regulations, and design control.
- Demonstrated ability to perform the essential duties of the position with or without accommodation.
- Advanced degree (Masters / PhD).
- Experience with next generation sequencing, immuno-histochemistry, in-situ hybridization, PCR
- Experience with instrument automation or scientific instrumentation.
- Experience with system analysis, model-based system engineering, and system architecture.
- Medical device experience.
- Six Sigma certification.
- Design for Six Sigma (DFSS) experience.
- Proficiency with formal requirements management tools.
$119,000.00 - $190,000.00
The annual base salary shown is for this position located in US - CA - San Diego on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.
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.
Not ready to apply? Join our talent community and stay up to date on what’s new at Exact Sciences.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company’s affirmative action program.
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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Scientific Services
SALARY
$117k-142k (estimate)
POST DATE
06/21/2024
EXPIRATION DATE
07/18/2024
WEBSITE
exactsciences.com
HEADQUARTERS
MADISON, WI
SIZE
3,000 - 7,500
FOUNDED
1995
TYPE
Public
CEO
KEVIN T CONROY
REVENUE
$1B - $3B
INDUSTRY
Scientific Services
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About Exact Sciences
Exact Sciences, focused on the early detection and prevention of colorectal cancer.
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