Engineering Program Manager in Sunnyvale, California at Cepheid

Date Posted: 11/10/2018

Job Snapshot

Job Description

Job ID: CEP002075

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

Engineering Program Manager Job Summary


The Engineering Project Manager will be responsible for planning, coordination, tracking, and successful implementation of medical devices, plastic consumables, molecular in-vitro diagnostic hardware, software, and system projects and for ensuring Engineering project and program consistency with corporate strategies and goals, product development processes, and quality system and regulatory requirements.


Responsibilities: 

• Lead the planning and implementation of multiple Engineering development programs

• Work side-by-side with Technical Leads in the planning, coordination, and implementation of Engineering, Software, Manufacturing, and Consumables projects

• Facilitate the definition of project and program scope, goals and deliverables

• Utilize Danaher Business System Toolkit to manage projects to (1)  deliver project on time (2) Manage and report project and program resource allocations (3) Develop manage and report project and program budgets (4) Meet stringent quality requirements that meet regulatory and customer standards 

• Develop, document, and manage full scale project plans, including task lists, schedules, and resource requirements

• Day-to-day management of cross-functional Core Teams including team members from departments such as Biology, Engineering Development, Sustaining Engineering, Marketing, Regulatory, Clinical Affairs, Quality, Manufacturing, Supply Chain and others

• Manage and lead globally dispersed teams through multiple communication levels and mediums throughout the organization as well as external collaborators

• Provide direction and support to project team members as appropriate

• Create and maintain Design History Files, Meeting Artifacts, Risk Management Files, and other ISO/FDA required project and product documentation

• Monitor and report regularly on progress of the project to all stakeholders as well as to executive management

• Present regular reports defining project progress, problems and solutions

• Implement and manage project changes and interventions to achieve successful project outputs

• Assess results of projects and incorporate improvements into the overall product development and project management processes. Contribute to continuous improvement projects for project documentation, templates, and Product Life Cycle (PLC) processes

• Contribute to the development of Project Management Office (PMO) standards and best practices

• Develop and deliver project management and product development process training


Job Requirements



Qualifications

Required Knowledge - Skills - and Abilities: 

Education and Experience

• Bachelor’s degree in Bioengineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or equivalent combination of education and experience to perform at this level is required.

• Candidates must have a background or equivalent experience in one or more of the following disciplines within the medical device field: Software Engineering, Hardware Engineering, Manufacturing New Product Introduction (NPI)/ Product Transfer, and/or Consumables.

• ≥ 5 years of direct work experience in a medical device project management capacity is required, with experience in all aspects of product development and sustaining projects; planning, execution and product launch.

• Demonstrable track record of managing complex medical device projects delivering successful global product launches.

• Knowledge of both theoretical and practical aspects of project management is required

• Proficiency in MS Office applications (Project, Power Point, Visio, Outlook, Excel) is required

• Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003, FDA regulations is required


Key competencies

• Superior interpersonal skills with demonstrated competencies in team building, influencing and negotiation, and conflict management.

• Excellent communication skills, both written and verbal. Comfortable presenting to and communicating with cross-functional groups at multiple levels of corporate structure

• Proactive, hands-on management style

• Ability to coach/mentor and train others

• Strong analytical and problem solving skills, creative in finding innovative solutions to project execution or process problems

• Demonstrated leadership strengths, adaptable to changes in project scope or direction as appropriate

• Excellent decision-making skills and comfort in influencing and leading cross-functional groups


Preferred Qualifications: 

• PMP (Project Management Professional) certification is a highly preferred

• The preferred candidate will have significant experience managing IVD products and devices




Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.