- 6511 Stone Crossing Dr. Apt. E Ÿ Xxxxxx, IN xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Dear Hiring Manager,

        In response to a job vacancy posting for the position of ________________, I am pleased to tender my application to become part of your team. My resum is attached for your review and consideration.

What I offer is my baccalaureate degree in Mechanical Engineering with Bioengineering Applications Specialty and Minor in Business, and backed by more than 9 years providing high-performance process, methods, metrological, and product design in the manufacturing, bioengineering, and pharmaceutical/ healthcare sectors. I am currently with Eli Lilly & Co. in Xxxxxx, IN as a Senior Process Engineer, following my tenure as Test Methods & Metrology Engineer. Prior to this, I was with Biomet in Warsaw, IN as Sports Medicine Department Co-op. For more details, please take a moment to go through my resum .

In leveraging my engineering and managerial competencies in high-technology manufacturing, I also bring to the table my personal strengths that include a passion for achieving business objectives through sustainable process-centric and results-driven work excellence. Along the way, I have also proven my interpersonal communication skills that help build relationships with the people I work with, including senior management, stakeholders, and industry professionals that create a harmonious and collaborative work environment in achieving shared commitments.

I am confident that my education, experience, and personal strengths offer the right mix of qualifications that qualify me as a suitable candidate for the vacancy, one who can help achieve your objectives as part of your team. Should you need further clarification, or would prefer to schedule an interview, please do not hesitate to reach me through my phone or email address indicated in the heading. Thank you for considering me, and I look forward to hearing from you soon.

Sincerely,

YYYYYY X. YYYYYY

Attachment: Resum

- 6511 Stone Crossing Dr. Apt. E Ÿ Xxxxxx, IN xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Design Engineer (Bio-Medical Products)

Qualifications Profile

    Self-motivated and challenge-driven engineer and solutions provider in bio-engineering, process, methods, metrological, and mechanical design, with more than 9 years in the biomedical manufacturing and pharmaceutical/ healthcare sectors.

-    Exhibited strong dedication to process efficiencies in process and validation designs and execution for the French manufacturing site of a French pharmaceutical company resulting in $6.5k/$13k savings.

-    Detail-oriented, analytical and methodical with critical thinking to resolve complex technical design issues requiring root cause data analysis that translate findings into actionable recommendations for a biomedical company,

-    Exceptional people management and interpersonal communication skills that inspire confidence across a rapidly growing cross-functional organization while forging teamwork synergies with colleagues across diverse ethnicities.

    Proven flexibility and adaptability with quick learning abilities to reach high productivity levels in fast-paced work environments and new or demanding assignments.

    Well-organized and resourceful with multitasking and prioritization skills that optimize limited resources to achieve outstanding results.

Key Expertise

Operations Management

    Strategic Planning & Execution

    Device Design Engineering

    Manufacturing Operations Management

    Technical Service Support

    Product Development

    Project Management

    Change Management

    Total Quality Management

    Process/Workflow Improvement

    Continuous Quality Improvement

    Statistical Quality Control

    Production Planning & Control

    Relationship Management (Clients, Stakeholders, & Suppliers)

    Policies & Regulatory Compliance (i.e. OSHA, ISO, FDA/GMP, etc.)

    Staff Supervision & Training

    Records & Document Management

Technical

    Test Systems Management

    Metrological Systems Design

    Statistical Data Analysis

    Technical Failure Mode Analysis

    Apps: TrackWise, Regulus, JMP Statistical Analysis, FactoryTalk, In-sight Explorer, & SolidWorks

    Engineering Design Tools: Unigraphics NX5 CAD

    Productivity Tools: MS Office (Word, Excel, PowerPoint, Access, & Outlook), Acrobat, & Lotus Notes

Professional Experience

Eli Lilly & Co. Xxxxxx, IN

Ÿ Responsible for overseeing process development & optimization, and maintenance that enable 3 medical device assembly & manufacturing lines to operate safely and efficiently over a 24/7 operation.

Ÿ Provide manufacturing data covering production control, reliability, and process capability to monitor and improve production output and outcomes in compliance with design specifications, safety regulations, and quality standards.

Ÿ Collaborate with Operations, Maintenance, Quality Control, Procurement, Project Engineering and Finance to scope, develop and execute business improvement projects.

Ÿ Execute Root Cause Failure Analysis for various equipment deviations from expected performance parameters.

Ÿ Developed, validated and transferred test systems and validation methods behind in-process control, lot release and compliance testing of cartridges, syringes, single-use and reusable devices, providing, global multi-site support of cartridge test methods and primary container closure interface.

Ÿ Created test method co-validation for French manufacturing site resulting in $6.5k/$13k savings per method transfer

Ÿ Supported Axiron Gen 3 product launch, leading successful FAT in Ulm, Germany while documenting post product launch learnings to enhance future FAT executions.

Ÿ Performed on-site installation of cartridge PGF, FTL and pre-filled axial pull test methods and qualification activities for Zwick test systems at manufacturing sites in France and Italy, conducting statistical data analysis and DOE s for test method development, validation, and transfer.

Ÿ Built sustainable professional relationships and team environments with clients, stakeholders and business partners.

Provided corrective and preventive action as an originator and Lead Investigator conducting root cause analysis

Demonstrated understanding and implementation of ISO and GMP requirements and compliance

- 6511 Stone Crossing Dr. Apt. E Ÿ Xxxxxx, IN xxxxxx ( (xxx-xxx-xxxx * abc@xyz.com

Professional Experience (continued)

Biomet Inc. Warsaw, IN

Ÿ Designed and executed projects from conception to production for various shoulder, foot, ankle, and hand repairs utilizing PEEK, biodegradable LactoSorb, titanium, and nitinol ingredients aimed at producing and marketing reconstructive products for orthopedic surgery, neurosurgery, and craniomaxillofacial surgery.

Ÿ Designed and modeled complex calcaneus and ankle fusion trauma plates using NX5 software, developing bone model density configuration specifications of test constructs for mechanical testing equivalent to foot, ankle, hand, and wrist bones prior to market penetration.

Ÿ Machined and modified surgical rapid prototypes and products, efficiently harnessing knowledge in vertical mill, lathe, and wire EDM knowledge for machining operations that enhanced design in manufacturing knowledge.

Ÿ Assembled and validated suture anchor designs with mechanical testing, completing 510k FDA documentation.

Ÿ Directed product development meetings, providing technical support to vendors and sales force, and coordinating with operations and marketing in arriving at the most cost efficient process design and manufacturing measures that meet market needs.

Education & Credentials

Ÿ KETTERING UNIVERSITY Flint, MI (2012)

B.S. in Mechanical Engineering, Bioengineering Applications Specialty; Minor: Business, GPA: 3.58 (Cum Laude)

Awards/Recognition

Ÿ Customer Focus Award recipient for PTL/FTL equivalency investigation (Q3 2014)

Professional Affiliations

    Recruitment Team Member: National Society of Black Engineers (NSBE) (Jul 2012 Present)

    Facilitator: Center for Leadership Development (Jan 2016 Present)

    Member: Eli Lilly Xxxxxx Device Manufacturing Lab HSE Team (Feb 2002 Mar 2016 )

    Intern Supervisor: Eli Lilly and Company (Summer 2015)

    Member: Communications Committee, International Society of Pharmaceutical Engineers (Jan 2014 Mar 2016)

    Social Chair (2013), Training and Onboarding Chair (2014), Senior Governance Chair (2015),

New Hire Engineering Network (Ignite),

    Facilitator: Minority Engineering Program of Xxxxxx (MEPI) (Jul 2012 Dec 2015)