Rangam

Manager, NPD Program Management
Manager's Update
<ul>
<li>Location: Irvine, CA 92618
</li>
<li>Work Arrangement: 100% onsite
</li>
<li>Contract Duration: 12 months
</li>
<li>Education: Bachelor's degree (BS) required
</li>
<li>Experience: 6+ years of hands-on NPD project/program management
</li>
</ul>
1. Job Summary
The New Product Development (NPD) Program Manager will lead and manage new product development projects within a regulated industry, preferably medical devices. The role requires a minimum of 6 years of hands-on NPD project/program management experience, with the ability to coordinate cross-functional teams across R&amp;D, engineering, quality, regulatory, and other stakeholders in a large, matrixed organization.
The ideal candidate will have experience managing product development from concept through commercialization, a strong understanding of Quality Management Systems (QMS), and the ability to drive programs independently. Experience with algorithms, software, embedded software, and electromechanical products is particularly valuable.
2. Core Responsibilities
<ul>
<li>Lead and manage new product development projects from concept and development through commercialization, where applicable.
</li>
<li>Coordinate cross-functional teams across R&amp;D, engineering, quality, regulatory, and other business functions.
</li>
<li>Develop and manage project plans, timelines, milestones, dependencies, deliverables, and execution activities.
</li>
<li>Navigate a large, matrixed organization to align technical teams, stakeholders, and leadership.
</li>
<li>Ensure product development activities align with applicable quality systems and regulated-industry requirements.
</li>
<li>Monitor project progress, resolve execution challenges, and drive projects toward successful completion.
</li>
<li>Manage assigned projects and team members, progressing toward independent ownership of the overall program.
</li>
<li>Communicate project scope, team structure, responsibilities, and outcomes to relevant stakeholders.
</li>
</ul>
3. Core Priorities
<ol>
<li>Hands-on NPD experience: At least 6 years of direct experience managing new product development projects, not just general project coordination.
</li>
<li>Medical device industry preference: Prioritize candidates with medical device product development experience.
</li>
<li>R&amp;D and product development: Look for candidates who understand the product development lifecycle and have delivered projects through key development milestones.
</li>
<li>Quality Management Systems: Strong understanding of working within a regulated quality environment.
</li>
<li>Cross-functional leadership: Ability to coordinate engineering, R&amp;D, quality, regulatory, and leadership stakeholders in a matrixed organization.
</li>
<li>Demonstrated project delivery: Candidates should be able to explain successful projects, their individual contributions, team size, technical disciplines involved, and outcomes.
</li>
<li>Technical product development exposure: Algorithm, software, embedded software, electromechanical, disposable, cable, or capital-project experience is valuable.
</li>
<li>Independent program ownership: Ability to take initiative, work autonomously, and eventually manage the entire program with minimal guidance.
</li>
</ol>
4. Must-Have Qualifications
<ul>
<li>Minimum 6 years of hands-on NPD project/program management experience.
</li>
<li>Experience in a regulated industry; medical devices strongly preferred.
</li>
<li>R&amp;D and new product development experience.
</li>
<li>Understanding of Quality Management Systems (QMS).
</li>
<li>Experience coordinating cross-functional teams in a large, matrixed organization.
</li>
<li>Demonstrated involvement in successfully executed product development projects.
</li>
<li>Strong communication, stakeholder management, organizational, and problem-solving skills.
</li>
<li>Bachelor's degree (BS).
</li>
<li>Willingness and ability to work 100% onsite in Irvine, California.
</li>
</ul>
5. Nice-to-Have Qualifications
<ul>
<li>Medical device industry experience, particularly in product development.
</li>
<li>Experience taking products from concept through commercialization.
</li>
<li>Algorithm portfolio, software development, or embedded software project experience.
</li>
<li>Electromechanical product development experience.
</li>
<li>Experience with disposable products, cables, or capital projects.
</li>
<li>PMP certification.
</li>
<li>Familiarity with OnePlan.
</li>
<li>Experience using Microsoft Project and Office Timeline Pro.
</li>
<li>Experience managing complex programs involving multiple technical disciplines and large cross-functional teams.
</li>
</ul>
6. Not a Good Fit
Avoid or deprioritize candidates who demonstrate the following:
<ul>
<li>Pharmaceutical-focused experience: Pharma candidates are explicitly discouraged, even if they have worked in a regulated environment. Pharmaceutical development is not considered a suitable match for this NPD role.
</li>
<li>Clinical or drug development focus: Candidates whose primary experience is clinical operations, clinical trials, drug development, or pharmaceutical project management rather than product development.
</li>
<li>General project management only: Candidates without direct, hands-on NPD experience.
</li>
<li>No R&amp;D or product development exposure: Candidates whose experience is limited to business operations, administrative coordination, or nontechnical project delivery.
</li>
<li>Limited quality-system knowledge: Candidates unable to demonstrate experience working within a regulated quality environment.
</li>
<li>Weak cross-functional leadership: Candidates who have not coordinated technical teams, engineering functions, or multiple stakeholders in a matrixed organization.
</li>
<li>No demonstrable project outcomes: Candidates unable to explain their project scope, responsibilities, team involvement, or achievements.
</li>
<li>Onsite constraints: Candidates unwilling or unable to work onsite in Irvine, CA.
</li>
</ul>
Recruiting recommendation:
Prioritize medical device NPD Program Managers with 6+ years of direct product development experience, QMS knowledge, R&amp;D exposure, and strong cross-functional leadership. Treat PMP, OnePlan, and software/algorithm experience as differentiators rather than mandatory requirements.
Must Have
<ul>
<li>Experienced in large matrixed Orgs</li>
<li>MDR and PDP experience</li>
<li>Medical Device Dev'l-SW, FW, HW, Disposables</li>
<li>NPD R&amp;D</li>
</ul>
Nice To Have
<ul>
<li>Agile/Scrum methodologies</li>
<li>PMP</li>
<li>Project management software: Jira, Microsoft DevOps, etc.</li>
</ul>
Job Description:
<ul>
<li>The NPD (New Product Development) Program Manager in Client Advanced Patient Monitoring (APM) PMO Team will be responsible for successfully leading NPD teams through the various stages of product and algorithm development, clinical evaluations, operational readiness, and commercialization for new and improved Hemodynamic Monitoring products and related accessories and disposables.</li>
<li>This person will be responsible for initiating, planning, budgeting, executing, documenting, controlling, and managing all aspects of program(s), to ensure on-time commercialization of new products and technologies that uphold Client APM’s best in-class quality standards and business objectives.</li>
</ul>
Key Responsibilities:
<ul>
<li>Manages one or more large scale to enterprise-wide projects within program, assuring strict adherence to Client APM’s Quality Systems and Change Control Process</li>
<li>Facilitates the creation and approval of business cases within the program, and coordinates the sharing and prioritization of resources among projects</li>
<li>Develops a detailed plan for the program and manages program change accordingly</li>
<li>Executes program plans (quality, risk, communication, staffing, etc.) and communicate program status and data to maintain accurate and current program information for the use of stakeholders</li>
<li>Leads core team meetings and other necessary meetings to drive best in class program execution; Continually improves quality and effectiveness of how meetings are run, decisions are made, and how work gets done</li>
<li>Serves as a project and program management subject matter expert, including guiding and mentoring peers</li>
<li>Demonstrates high emotional intelligence; builds trust, rapport and respect with project team members and stakeholders; Engages in honest and transparent conversations</li>
<li>Creates a culture where teams can act with a high sense of urgency and accountability to meeting/exceeding individual and project goals</li>
<li>Understands complex problems and drives the team to effective resolution</li>
<li>Displays perseverance and continues appropriate forward momentum by keeping core team engaged, even when faced with crisis, and/or changes</li>
<li>Demonstrates strong ability to influence downward, horizontally, and upward.</li>
</ul>
Experience:
<ul>
<li>A minimum of 6 years of hands-on experience managing New Product Developments projects and/or programs of increasing complexity -- Required</li>
<li>Demonstrated track record of successfully managing and leading projects in the medical device industry that incorporate a mix of Software, Firmware, and Hardware and Disposable components – Required</li>
<li>Proficient understanding of Medical Device Regulations and Product Development Process – Required</li>
<li>Demonstrated track record of leading within complex organizations requiring strong influence management skills</li>
<li>Proven expertise in usage of MS Office Suite and related project management systems</li>
<li>Ability to see the “big picture” and determine course of action from an overall “best for the business” perspective</li>
<li>Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions</li>
<li>Ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals.</li>
<li>Effective decision-making skills -- ability to negotiate and balance decisions and priorities across needs of several functional departments. Makes timely decisions in the face of risk and uncertainty</li>
</ul>
Additional Skills:
Working knowledge of Agile/Scrum methodology and related project management software: Jira, Microsoft DevOps, etc.
<ul>
<li>Strict attention to detail</li>
<li>Ability to lead meetings with external representatives</li>
<li>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 environment and prevention of pollution under their span of influence/control</li>
</ul>
Education:
<ul>
<li>Bachelor's Degree in (Mechanical, Biomedical, Systems, Electrical) Engineering or related field – Required</li>
<li>Master's Degree or equivalent – Preferred</li>
<li>PMP Certification - Plus</li>
</ul>

RCI-BDX-4594 New Product Development Program Manager

RCI-BDX-4594 New Product Development Program Manager

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