Associate Director - Device Commercialization

BioSpace; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

A global healthcare leader in Indianapolis is looking for an Associate Director of Device Commercialization to oversee commercialization of medical devices from development to launch. The role involves leading cross-functional teams, ensuring safety and quality, and optimizing business processes. This leadership position requires over 5 years of relevant experience and a strong background in project management within the medical device industry.

Benefits

Comprehensive benefit program

401(k) and pension plan

Flexible benefits and well-being programs

Qualifications

• 5+ years of experience in asset/project delivery and/or medical device development.
• Demonstrated Project Management skills and familiarity with medical device quality requirements.

Responsibilities

• Lead medical device commercialization activities through development to launch.
• Manage resource workload and allocate across project portfolios.
• Drive continuous improvement in commercialization processes.

Skills

Project Management

Strategic Thinking

Communication and Influence

Education

BS Engineering or relevant STEM degree

Job description

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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Brand Description

This position will provide leadership for Commercialization Global Program Managers (GPM’s) who lead medical device and drug/device combination product commercialization actives through mid- to late-stage development into manufacturing readiness and commercial launch. The role reports into the Indianapolis Device Manufacturing (IDM) organization, and is responsible for the successful maintenance, execution and optimization of Device Commercialization business processes, working across numerous business units, cross-functional teams in development and manufacturing, and external partners (design partners, injection molding and assembly equipment builders, and contract manufacturers) to develop integrated project schedules for new products and assets. The role will focus on delivery, operational readiness and launch of manufacturing assets, knowledge transfer and technical capabilities, Contract Manufacturer evaluation and selection, CM partner integration and readiness, and gap assessment coordination and resolution.

Key Objectives/Deliverables

Safety and Quality

• Ensure staff is current with all relevant, required training
• Drive integration of safe behaviors into daily work by participating in safety initiatives and engagement opportunities, and modeling and reinforcing expectations for safe work practices
• Ensure HSE focus as part of Commercialization deliverables and activities, including travel safety
• Drive compliance with Lilly standards, policies, and procedures through assessments, quality and compliance audits, and surveillance activities
  
  
  

People

• Build and support Development Plans and Career Maps for employees
• Assist in identification and mitigation of technical capability gaps across IDM
• Identify and leverage contract staffing and consultants to fill capacity and capability gaps
• Manage resource workload and allocation across the entire project portfolio
• Optimize organizational design/structure and recommendations for the business planning process around staffing levels
• Proactively recognize and reward achievements and provide candid feedback for development
• Train and certify project team resources and Lilly partners (CM’s, OEM’s and service providers) around Lilly expectations
• Plan and optimize team travel to balance business needs and work/life for employees
  
  
  

Business Leadership

• Own and execute the Commercialization Business Processes, and drive continuous improvement and optimization of those processes
• Establish and implement Commercialization best practices, through after-action reviews, organizational learning, and application of archetype-based project and resource models
• Proactively communicate program and team progress to stakeholders, team members, and peers
• Partner with Manufacturing Strategy, Platform Senior Directors, IDM Asset Delivery and other functional teams to define robust and executable commercialization strategies and plans
• Work with Procurement, Manufacturing Finance, and Device Development teams to establish capital estimates, project budgets, and volume-based COPS targets
• Manage and synchronize the teams and functions across sites to enable effective commercialization of new products and capacity expansion for existing platforms
• Partner with Regulatory to establish submission plans that synchronize with manufacturing plans
• Partner with receiving sites (Lilly, Partner or CMO) to establish robust Tech Transfer plans
• Develop and communicate department metrics that provide a foundation for continuous improvement
• Ensure appropriate allocation of employee time to projects, development, and administrative work
• Engage and influence project and process teams to escalate and resolve issues and barriers
  
  
  

Project and Resource Management

• Estimate resources needed from all functions to execute commercialization projects
• Maintain resource planning models to aggregate resource needs as input to strategic and business planning activities
• Network with stakeholder management to assure resource availability for the projects, then maintain communication of project status, changes & personnel performance on the project
• Track and report program metrics for schedule, COPS, scope, capital budget, and resourcing
• Encourage and support proactive Design for Manufacturability (DFM), Design for Assembly (DFA), Safety by Design, and Quality principles for all projects and platforms
• Benchmark, develop, share, and implement new technology to optimize value and reliability
  
  
  

Minimum Requirements

• 5+ years of experience in asset/project delivery and/or medical device development & commercialization
• Demonstrated Project Management skills
• Familiarity and practical experience with medical device / combination product quality & regulatory requirements, including GMP/CFR, EU MDR, ISO and IEC requirements
• Familiarity with related technologies (e.g. plastic injection molding, high-speed automation)
• Ability to communicate and influence effectively across functional groups and leadership teams
• Strategic thinking and capability
• Capability to prioritize and multi-task effectively
• Ability to establish and maintain a safe work environment for team and partners
• Experience in manufacturing operations and/or manufacturing support functions.
  
  
  

Education Requirements

• BS Engineering or relevant STEM degree
  
  
  

Additional Preferences

• Project Management certification (PMP)
• Six Sigma/Lean certification (Black Belt/Green Belt)
  
  
  

Other Information

• Some domestic and international travel required (10-20%)
  
  
  

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Sales and Business Development

• Industries

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