Associate Director Device TS/MS Product Engineering

Out in Science, Technology, Engineering, and Mathematics; Indianapolis (IN); On-site; USD 118,000 - 174,000; Full time

Job summary

A leading company in healthcare is seeking a Product Stewardship Team Lead. This role involves overseeing the device portfolio, ensuring compliance, and driving continuous improvements. Candidates should have a strong engineering background, leadership skills, and experience in product design and manufacturing.

Benefits

401(k) and pension plan

Comprehensive medical, dental, and vision benefits

Vacation and leave benefits

Employee assistance program

Fitness benefits and activities

Qualifications

• Leadership capabilities are essential to drive team and project success.
• Knowledge of pharma and combination product manufacturing required.
• Understanding of ISO and GMP regulations is crucial for compliance.

Responsibilities

• Lead a team of product stewards ensuring compliance and governance.
• Establish and execute technical processes supporting manufacturing activities.
• Drive engineering rigor and build technical capability across teams.

Skills

Leadership Capability

Operational Excellence

Root Cause Analysis

Understanding of GMP

Education

BS or higher in Engineering

Job description

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.

Organization Overview:

The Indianapolis Device Manufacturing site provides ownership and oversight of the Lilly Commercial Device portfolio. Within the TS/MS Product Engineering organization, the Product Stewardship teams own the design of combination product devices post-launch through the product lifecycle. The Product Stewardship team drives activities to ensure robust control strategy for manufacturing of device components across the Contract Manufacturing network, partnering with the Device Development Organization (DDCS) to successfully tech transfer new device products to manufacturing, assess product performance in the field on a routine bases through technical assessments and complaint investigations, and monitor the risk profile of our products to ensure acceptability.

This role will lead a team of product stewards - supporting career growth and development, ensure appropriate capability in place to support the business, improve and simplify processes, and represent the function to leadership both within and beyond the site.

Responsibilities:

• Develop, recruit and retain qualified personnel required to provide technical governance of the global design and specifications of the entire Lilly device portfolio and marketed lifecycle as well as anticipated stewardship roles to support implementation of Commercialization Projects.
• Ensure all devices are maintained in a state of compliance
• Establish and execute technical governance processes, and support manufacturing activities
• Participate in leadership governance processes - risk management governance, change review board, deviation review board, science and engineering lead team, quality lead team, and Device Safety Lead Team.
• Influence device product designs and control strategies being developed by DDCS with a particular focus through the Design for Manufacturability input/gateway.
• Receive and own device designs and design control from DDCS when device products launch. Provide ongoing product design stewardship for marketed device products, including owning and driving continuous improvements in the product designs and control strategies.
• Own and clarify TS/MS business processes across the device network. This includes developing and maintaining standards and processes by which device manufacturing processes are qualified and product life cycle risk management is controlled.
• Coordinate and continuously improve the execution of core TS/MS business processes across the global device manufacturing network of Contract Manufacturers.
• Act as a strong technical leadership voice for IDM. Drive engineering rigor. Build technical capability in the organization. Manage technical experts for product support across the device organization.
• Provide business needs through the business planning process (long range and yearly plans). This will be for needs across the corporate device organization. It will include asset recapitalization plans, new site start up, regulatory submissions, headcount needs, personnel capability development, and project integration.
• Provide Human Resource Management for all employees.

Basic Requirements:

• BS or higher in Engineering (preferably Mechanical or Electrical)
• Demonstrated Leadership Capability
• Strong practical experience with Operational Excellence and Root Cause Analysis
• Knowledge of pharma and/or combination product manufacturing (ideally discrete manufacturing)
• Understanding of GMP and ISO requirements for Combination Products, Needle Injection Systems, and/or medical devices

Additional Skills/Preferences:
Experience with either Combination Product or Medical Device design and manufacturing

Experience with Risk Management, ISO 13485 and ISO 11608

Additional Information:
This role supports global device design and manufacturing and thus requires some domestic and international travel.

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.

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