Job Description

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Medical Devices Project Manager

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NOTE: THIS IS AN ONSITE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)

*** Candidate must be authorized to work in USA without requiring sponsorship ***

Position: Medical Devices Project Manager (Job ID # CFNJP00052310)

Location: Irvine CA 92603

Duration: 12 months + Strong Possibility of Extension

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The Manager, Project/Program Management will be responsible for successfully leading project and program teams through various stages of product development, clinical evaluations, operational readiness, and commercialization for new and improved products and related accessories and disposables. The role involves initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of projects and programs to ensure on-time commercialization of new products and technologies that upholdbest-in-class quality standards and business objectives.

Key Responsibilities:

• Manage one or more large-scale projects/programs, ensuring strict adherence to Quality Systems and Change Control Process.
• Facilitate the creation and approval of business cases within the program and coordinate the sharing and prioritization of resources among projects.
• Develop a detailed plan for the program and manage program changes accordingly.
• Implement program strategies related to quality assurance, risk management, communications, staffing, and other core areas. and communicate program status and data to maintain accurate and current program information for stakeholders.
• Facilitate core team meetings and other required meetings to support program execution; regularly assess and enhance meeting processes, decision-making, and workflows.
• Serve as a project and program management subject matter expert, including guiding and mentoring peers.
• Demonstrate high emotional intelligence; build trust, rapport, and respect with project team members and stakeholders; engage in honest and transparent conversations.
• Create a culture where teams can act with a high sense of urgency and accountability to meet/exceed individual and project goals.
• Understand complex problems and drive the team to effective resolution.
• Display perseverance and maintain appropriate forward momentum by keeping the core team engaged, even when faced with crises and/or changes.
• Demonstrate strong ability to influence downward, horizontally, and upward.

Experience:

• A minimum of 6 years of direct experience managing New Product Development projects and/or programs of increasing complexity.
• Demonstrates a record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Thermoplastic Hardware and Disposable components.
• Proficient understanding of Medical Device Regulations and Product Development Process.
• Demonstrated record of leading within complex organizations require strong management skills.
• Proven expertise in the usage of MS Office Suite and related project management systems.
• Ability to see the “big picture” and determine the course of action from an overall “best for the business” perspective.
• Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to work cooperatively at all levels in a matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
• Demonstrated proficiency in decision-making, with the capability to negotiate and balance priorities across multiple functional departments. Makes timely decisions in the face of risk and uncertainty.
• Familiarity with Agile and Scrum methodologies, as well as project management software such as Jira and Microsoft DevOps.
• Meticulous attention to detail.
• Ability to lead meetings with external representatives.
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.
• Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field.
• Master's Degree or equivalent – Preferred.
• PMP/Agile/Scrum Certification – Plus.

Preferred Industry Experience:

• Experience in the medical device industry is highly preferred.
• Experience in the pharmaceutical, biotechnology, or healthcare sectors may be considered.

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If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. We're driven, people driven.

Bhupesh Khurana

Senior Technical Recruiter

Email: [email protected]

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients’ businesses forward.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.

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