Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies, or growing efficiency in their laboratories, we are here to support them.
We are seeking a software project lead role who plays a liaison between internal/external customers and the software team. The individual will synthesize user requirements and support the development of software solutions. With a strong self-motivation for innovation, product development and improvement, you will help identify new opportunities to improve the analytical application for existing products and for the products under development in LDT/regulated market segment. You will also be responsible to ensure that software projects run on schedule, meet scope and requirements, and that all software activities and tasks are completed in accordance with design compliance in LDT/regulated environment. The role involves attending core team meetings; coordinating with project team members outside of the software group; preparing, maintaining and supervising software plans and report documentation; resource planning and management; and resolution of issues that arise throughout the software development cycle. You will coordinate to ensure accurate completion, overcome obstacles, and mitigate identified risks.
ESSENTIAL JOB RESPONSIBILITIES:

• Represent Software R&D lead in project teams
• Gather, analyze, document, and validate internal and external customer requirements
• Work with product managers, software development, UI/UX, and assay development teams to create software solutions for new assays and products
• Building internal and external training materials
• Collaborate with product management and key collaborators to define the scope of each software release, with an eye on the product development roadmap
• Plan and manage software development, testing and related activities and timelines for software development projects
• Estimate overall engineering effort and collaborate with management to acquire and enable the vital resources
• Author, review, and approve software development plans and report documentation, ensuring design compliance for software
• Drive process improvement in software development and test methodologies, such as supervising software activities, project metrics reporting, and creating efficiencies
• Ensure all software related activities are accomplished according to guidance, design compliance with internal procedures, and suitability to intended use of the product
• Ensure that all projects toolsets and environments are in place for the project and are adopted and properly used by the software engineering team
• Participate in software hazard analysis to ensure a full understanding of safety risks for software products. Ensure that risk control measures are implemented correctly and verified accordingly with suitable traceability
• Collaborate with algorithm engineers to coordinate algorithm integration into the overall schedule
• Clearly communicate status of software product development to key collaborators via status updates
• Ensure completion and delivery of trace matrix from product requirements to test case results
• Ability to travel

PREFERRED:

• Strong science background
• 1 - 2 years wet lab experience
• Experiment in qPCR and/or CE instruments
• Strong solving skills
• Proven track record to solve analytical and scientific problems
• Ability to work in an office and laboratory
• Previous experience in Systems Integration and/or Field Application Support
• Regulatory and compliance awareness (e.g. ISO 9000, CLIA, FDA, ISO 13485, IEC 62304, ISO 14971. 21 CFR Part 820)
• Proficiency in general mathematics and formulas used in molecular biology and chemical calculations
• Proficient level with scientific functions in common analytical software such as JMP, Excel, Minitab, and etc.
• Medical device background and/or laboratory experience preferred

MINIMUM REQUIREMENTS:

• A Bachelor's degree, or higher in molecular biology/engineering with 5 or more years of proven experience in clinical laboratory instrumentation/software/systems
• Proven experience with laboratory techniques and analytical equipment such as nucleic acid extractions, qPCR, micro array, microfluidic systems
• Solid understanding of molecular clinical assay applications, engineering fundamentals, and technologies
• Experience in new product development from product realization to product launch
• demonstrated ability managing projects in laboratory setting
• proven experience leading software teams successfully

WHO YOU ARE:

• Understand customer expectations and empathize with customer needs
• Builds collaborative work relationships with different teams, including Assay R&D, Field Application, Product Management, Regulatory Affair, and Quality
• Thrive in a multifaceted and fast-paced environment
• Communicate at domain expert level when conveying sophisticated molecular user workflow
• The ideal candidate will exhibit a high degree of motivation, ingenuity and resourcefulness to help solve problems, invent new technology and develop innovative products.
• A sense of urgency, contagious humility and a natural curiosity
• Able to see tasks through to completion without significant guidance

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: ;br>
It is the policy of Thermo Fisher Scientific not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Compensation and Benefits
The salary range estimated for this position based in California is $129,400.00-$180,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: