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Head of Development - Director Level, Engineering

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HP

18d ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Product

AI generated summary

  • You need a master's in engineering, 15+ years in medical device/IVD development, assay expertise, program management experience, and skills in navigating regulations and cross-functional teams.
  • You will lead cross-functional teams, manage program timelines and resources, communicate updates, oversee deliverables, and ensure alignment with corporate strategies and industry best practices.

Requirements

  • Master’s degree in engineering, science or related technical discipline, plus at least 15 years of work experience.
  • Minimum of 10-years medical device and/or IVD product development experience, including Molecular Diagnostics
  • Experience in Assay Development.
  • Requires program manager experience from concept to initial commercialization for at least two medical or IVD devices; and, preferred at least one IVD medical device in Molecular Diagnostics
  • Experience working on regulated product developments (ideally IVDD 98/79/EG and/or FDA 510k) und QMS according to ISO 13485 or similar,
  • Experience leading core teams to successfully launch medical devices or IVD products is highly desired
  • Experience compliantly navigating US health care laws
  • Experience in working with external suppliers, including ODM (Outsource Design and Manufacturing) partners.
  • Experience managing and developing program plans and budgets
  • Experience successfully navigating cross-functional, matrixed organization
  • Skilled at identifying and consolidating complex, moving parameters across functions and product development
  • Ability to navigate processes with multiple stakeholders in various time zones
  • Ability to problem solve without extensive structural or operational support
  • Recognized industry and company expert regarding development of project and program management standards, equipment, and methodologies.
  • Integrating program management technologies, solutions, and practices into overall business architecture.
  • Demonstrated strategic business acumen, innovation, and success, with multiple examples of managing cross-business unit and organization-wide programs.
  • Outstanding analytical and problem-solving skills.
  • Experience in overall architecture of electronic hardware, materials, and component design and manufacture for products and solutions.
  • Excellent written and verbal communication skills; mastery in English and local language.
  • Ability to effectively communicate program management architectures, plans, proposals, and results, and negotiate options at the most senior organizational levels.

Responsibilities

  • Craft and execute comprehensive work-plans with various country teams across different technical fields spanning from Assay development, Hardware and Software engineering as well as designing microfluidic consumables.
  • Manage the program from a design concepts and feasibility throughout development, verification & validation, design transfer and start of production.
  • Lead a cross functional product development core team in the execution of deliverables. Work closely with Operations, Purchasing, Quality, Marketing, Regulatory, Legal, and other functions to ensure project priorities and decisions are consistent and accurate between teams and corporate strategic plans
  • Lead a cross functional joint project team with external partners to align and execute the project per contractual milestones
  • Communicate program updates to the core team, to functional management and to executive leadership both internally and externally
  • Ensure timely team completion of documents required for the product design history file
  • Ensure sufficient resources are identified and allocated to the program
  • Manage program by establishing goals and delivery plan, supervising task execution, and monitoring project progress to ensure that expected deliverables and targets are achieved on time and on budget
  • Lead the team to prepare for phase gate reviews and other go/no go decisions required by executive leadership
  • Provide a single point of contact for upper management and providing program leadership during the development efforts
  • Provide guidance in development, implementation and management of development programs consistent with organizational and industry best practices
  • This person may manage a small team of subject matter experts to help deliver the program.

FAQs

What is the primary focus of the Head of Development role?

The primary focus of the Head of Development role is to manage a large program aimed at developing innovative molecular diagnostic systems for point-of-care testing of infectious diseases.

What experience is required for this position?

Candidates are required to have at least 15 years of work experience, with a minimum of 10 years in medical device and/or IVD product development, including specific experience in molecular diagnostics and assay development.

Is experience with regulatory compliance important for this role?

Yes, experience working on regulated product developments, particularly with IVDD 98/79/EG and/or FDA 510k regulations, is essential.

What types of teams will the Head of Development lead?

The Head of Development will lead cross-functional product development core teams, as well as joint project teams with external partners.

How important are communication skills for this position?

Exceptional written and verbal communication skills are essential, as the role involves communicating program updates to various stakeholders, including core teams, functional management, and executive leadership.

What tools or methodologies should candidates be familiar with?

Candidates should be recognized experts in project and program management standards, methodologies, and technologies relevant to the development of molecular diagnostic products.

Are there opportunities for career development in this role?

Yes, the Head of Development will provide mentoring and guidance to lower-level employees, fostering their career development within the organization.

What are the essential personal skills needed for this position?

Essential personal skills include time management, task prioritization, team leadership, and a strong commitment to excellence.

What is the base pay range for this position?

The base pay range for this role is between $159,650 and $239,500 annually, with additional opportunities for bonuses and/or equity for US candidates.

Are there benefits offered to employees in this role?

Yes, the comprehensive benefits package includes health insurance, dental insurance, vision insurance, disability insurance, life insurance, and generous time off policies.

Technology
Industry
10,001+
Employees

Mission & Purpose

Our vision is to create a world where innovation drives extraordinary contributions to humanity. This vision guides everything we do, how we do it, and why we do it. Our technology – a product and service portfolio of personal systems, printers, and 3D printing solutions – was created to inspire our vision and we are doing everything in our power across climate action, human rights, and digital equity to make it so. We believe thoughtful ideas can come from anyone, anywhere, at any time. And all it takes is one to change the world.