Spec 3, Engineering Program/Project Mgmt

Sr Project Manager

Duration: 12 Months

Location: San Diego, CA 92121

Must Haves:

• Core team leader
• Cross functional program planning
• Product development of complex electromechanical devices
• Medical device and regulated environments (FDA, MDR)
• Cross functional program planning based on design control deliverables

Cross Functional Product Development:

• Electromechancial Product Development PM
• Design Control, cross functional program planning, Quality Systems deliverables. The PM will work with each function and map out when each deliverible will be met. GMPDS
• Med Device experience required

Duties and Responsibilities:

Understanding of milestone-based program planning (Daily Standup, risk register management, milestone tracking, visual planning) for ongoing projects.

Understanding of Scrum and all scrum ceremonies (Daily Standup, Sprint Planning, Sprint Retrospectives, Sprint Reviews) for ongoing projects.

Manages the overall platform program roadmap ensuring each element of the product development pipeline is delivered while communicating with the business and strategic partners to ensure optimization of the market window, customer requirements, product release strategies and competitive advantage.

Manage key external suppliers or design partners to ensure an integrated project planning.

Define program resource needs and negotiate program resourcing plans. Work with functional leaders to ensure the appropriate core team resources are committed to the program and contribute to required performance levels. Establish, delegate, and evaluate the roles, responsibilities, goals, deliverables and performance of core and extended team members.

Lead product development activity ensuring that a structured design and development process is followed, ensuring compliance with quality management systems and regulatory requirements, where applicable.

Lead the team to prepare for Phase Gate and other Go/No-Go decisions by Partner executive leadership, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data. Recommend ideal course of action, budget, and resource allocation to deliver the program in a timely and cost-effective manner. Accurately communicate risk, impact, and mitigation.

Ensure alignment across product value proposition, program scope, and strategic business objectives. Lead program planning process ensuring all requirements are clear and driven by market needs, customer insights and experience. Develop, refine, and monitor progress against an accurate overall integrated platform program plan with measurable milestones and goals that form the basis of functional workstreams and deliverables.

Ensure internal/external governance mechanisms, such as core team meetings, key technical design and commercial excellence and industrialization reviews are undertaken in a timely, comprehensive, and effective manner. Develop a mentality of collaboration, execution, and continuous improvement within the program through these mechanisms.

Drive mechanisms and management techniques that ensure an open and transparent approach to the identification, communication and timely resolution of issues, risk, and challenges affecting program deliverables.

Lead cross-functional teams through problem resolution including root cause analysis, corrective and preventive action. Constructively challenge the team and the organization to rethink assumptions and approach headwinds in new ways. Independently determine and pursue courses of action necessary to obtain desired results.

Ensure effective formal and informal communication mechanisms with the core and extended team members using a variety of tools and channels. Build high morale and ensure the entire team commits to the target goals and objectives by creating a common purpose and direction.

Knowledge and Skills:

Exceptional communications skills. Ability to communicate clearly and concisely to all levels of the organization, spanning cross-functional teams to business leadership.

Expert in cross functional/cross-sites/external strategic partner team leadership delivering critical business goals within a phase-gate based product development process.

Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.

Set clear objectives and measurements. Skilled at facilitating team dynamics. Fosters development in others. Creates strong morale and spirit on teams. Share wins and successes and fosters constructive challenge. Thrive in achieving success through others.

Possess the skills and aptitude to engage, influence, and direct all functions and partners involved in the development of new products. Anticipate and understand implications across all functions.

Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures. Drive for accountability within self and others.

Expert at leading complex programs delivering the right outcomes balancing on time delivery, budget, quality and market and customer expectations. Highly skilled in integrated program planning along with tactical project planning, risk management, project execution and communication to all levels of the organization.

Ability to take disparate data points and make sound business decisions and bring clarity to ambiguous situations. Look at the big picture and the long range with an instinct for trade-offs (i.e. user experience vs. technical aspects / short vs. long term / risk vs. reward / resources vs. budget).

Time management, self-control, continuous learning, drives for order yet flexible and nimble. Versatility of thought and action in unanticipated circumstances using structured tools at his/her disposal to respond effectively and resolve unanticipated changes.

Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements. Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.

Education and Experience:

Bachelors degree is required, with an MBA or other advanced business/management degree preferred.

Minimum of 8-12+ years of experience in successfully leading complex, multiyear new product development programs delivered through high performing cross-functional teams based in a matrix organization.

Experience in medical device industries required, including experience in FDA or other regulated environments required. Knowledge of the medical device industries beneficial integrating science and technology into business processes

Exceptional analytical, critical thinking and problem-solving skills coupled to strong business, strategic and financial acumen.

Highly effective interpersonal skills on a cross-cultural level with excellent oral, presentation, and written communication skills, including engagement with Executive level management

Exceptional leadership qualities consistently delivering results. Inspirational and motivational balancing accountability with mentorship and support. Strategic and yet able to comprehend and manage details.

Expert in balancing risk with progress and a timely path for escalation.