Principal Development Engineer
Research and Development
PrincipalDevelopmentEngineerDevice&CombinationProducts
“Principal Development Engineer - Device & Combination Products at Principal Development Engineer. Skills: Project Management, Device Development, Risk Management, Cross-functional Leadership. Provide project leadership. Ensure cross functional deliverables”
What You'll Achieve.
Execution and delivery of assets/projects from early to late-stage development through launch; Ensure all required cross functional deliverables are achieved on or ahead of schedule; Within budget target; Quality that meets or exceeds business needs; High team performance and individual achievement; Achieve meaningful outcomes; Create business impact
Industry & Context.
Strategic problem-solving; Independent problem solving; Risk analysis; Risk mitigation; Identify options to de-risk project plans; Capitalize on opportunities; Develop alternative development options
Less than 10% travel, Work Location Assignment: Hybrid, Permanent work authorization in the United States, U.S. work visa sponsorship is not available
What They're Looking For.
Must Have
bachelor's degree with at least 6 years of OR a master's degree with at least 5 years of OR a PhD with 1+ years of experience, Mastery of project management skills, product development, Minimum of 7 years in Project Management / Leadership, >7 years of experience in developing medical devices, combination products, pharmaceuticals, Experience working in multi-disciplinary teams, working independently in ambiguous situations/assignments, Planning experience, fiscal awareness, sound knowledge of the medical device development process, advanced technical knowledge within the applicant’s own discipline, knowledge of other related disciplines, Demonstrated influencing and negotiating, proven skills in developing others within own functional area, Ability to identify and develop options to support short to mid-term goals, set direction for team, High awareness of personal limits, willingness to proactively consult others to ensure quality of judgement, independent problem solving, working with minimal direction, oral and written communication skills, analytical skills, computer skills, permanent work authorization in the United States
Nice to Have
Advanced degree (PhD, PharmD, MS), understanding of and experience in combination product development (drug plus device), Medical device development/design control experience, track record of performance on cross-functional teams, results through effective implementation of project management methodology, tools, and techniques, leadership skills, negotiation skills, interpersonal skills, communication skills, meeting facilitation skills, Experience with stakeholder management, governance management, communicating key messages to senior-level stakeholders, Demonstrated ability to utilize project management tools and techniques (such as developing integrated project plans, critical path management, project change control, project risk management, and decision analysis), Extensive hands-on experience using Microsoft Project or equivalent project planning system to create and manage project timelines, Track record for delivery against challenging personal and team goals, Proven ability to succeed in a fast-paced, challenging and complex matrix team environment, breadth of diverse leadership experiences and capabilities, ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes, create business impact, strongly collaborative behaviors, teamwork, expertise in team dynamics, coaching, negotiating, motivating, soft skills necessary to foster team effectiveness in a matrixed environment
What You'll Do.
Provide project leadership
Ensure cross functional deliverables
Lead operational planning for projects
Manage project budgets
Manage interactions with third party manufacturers
Negotiate resource allocation
Lead risk management plans
Drive creation/maintenance of project plans
Ensure compliance with policies
Communicate program information
How You'll Work.
Team & Collaboration
Works with key stakeholders in Commercial, Launch Excellence, GTEL; Interacts with stakeholders at all levels of management; Works with Procurement, External Supply and PGS sites; Facilitates team discussions for decision-making; Partners with team members and line function leadership; Ensures functional line leaders understand strategy; Collaborates with peers; Guides work of other colleagues
Communication Scope
Communication management; Effective, accurate, and timely communication of program information; Communicating key messages to senior-level stakeholders; Oral communication skills; Written communication skills
Process & Methodology
Project leadership, Operational excellence, Project planning, Program execution, Risk management, Budget management, Forecasting, Resource allocation, Critical path management, Project change control, Decision analysis, Project management methodology, Project management tools, Integrated project plans
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