Lilly Consultant Engineer-IDM in Indianapolis, Indiana
Position Brand Description:
Serve as Product Steward responsible for the global product design, specifications, materials, and technical agendas for one or multiple Lilly devices and for providing technical support to global device manufacturing operations with interface to all functional groups inside and outside IDM.
Key Objectives / Deliverables:
Work with internal and external partners to develop potential product and process improvements. Develop project alternatives to meet technical support needs, assisting in assessment and selection of improvement projects. Provide change control ownership and support.
Responsible for design control, validation and verification activities, and manufacturing control strategy. Develop specifications, protocols, sampling plans, engineering studies, technical reports, organize and facilitate Failure Modes, and Effects Analysis (FMEA) meetings
Write technical reports, validation plans, inspection procedures, test procedures, work instructions, change control documentation, deviations, development plans, internal contracts, device master record, and quality control plans.
Lead or participate on multi-functional project teams consisting of internal functional support as well as external design and manufacturing resources.
Provide support to product lifecycle management and monitoring processes such as PLRMR and GPA.
Participate in and support complaint investigation activities (both internal Lilly complaints and external customer complaints), and recommend product and/or process improvements as needed to address these complaints, and support maintenance and review of technical reports supporting common response language.
Participate in and support CMO Joint Process Teams to meet manufacturing objectives, as well as interface with Site Device Stewards to support wet site manufacturing activities.
Lead or participate in root cause investigation teams to develop and implement corrective and preventative actions that address design and manufacturability concerns.
Interface with the IDM Device Platform Advisors on the device strategy and technical agenda to lead applicable projects.
Participate in Design and Manufacturability reviews.
Minimum of two years experience in medical device manufacturing
Ability to drive integrated technical issues to resolution and develop and implement manufacturing operation improvements
Demonstrated high degree of ownership / accountability
Excellent written and oral communication skills including technical writing
Proven ability to organize and prioritize multiple tasks
Mechanical aptitude (ideally knowledge of mechanical equipment, controls, and validation for medical devices)
Ability to work independently as well as in a team environment
Proficiency in MS Excel/Word/PowerPoint
Ability to work across organizational and geographic boundaries (with Lilly sites, equipment and parts suppliers, vendors, contract manufacturers, and design firms)
Experience with CAD software packages (Solidworks, ProE, Inventor) and knowledge of current GD&T drawing practices
Deep technical expertise with device platforms, including design, materials of constructions, manufacturing process, and quality systems
Strong practical experience with C4I, Primary Loop, Operational Excellence, and Root Cause Analysis
Experience with manufacturing operations (ideally discreet manufacturing and/or high speed assembly operations)
Knowledge of drug product and medical device regulatory requirements (especially cGMP, 21 CFR 820, ISO 13485, ISO11608)
Demonstrated project management abilities, and excellent written and oral communication skills
Ability to direct and influence technical teams with team members dispersed across multiple sites and geographies
This role supports global device design and manufacturing, and thus requires some domestic and international travel (3-4 trips per year).
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Engineering Bachelor's Degree (Mechanical or Electrical Engineer preferred)
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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 39,000 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.
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