Test Engineering Lead

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Is Kymanox the right fit for you?

You want to make a difference and have an impact…

You enjoy having an influence in your day-to-day work…

You are motivated by working alongside a team filled with

subject matter experts who will help you learn and grow…

You wake up every day and do what you do

… because patients deserve better.

If this sounds like you, you’ve come to the right place.

Responsibilities:

Job Description:

This position is responsible for the strategic oversight and coordination of GxP and non-GxP projects at the Kymanox medical device and combination product testing laboratory, with specific focus in physical test method development and validation, as well as design verification planning. This position is based at the Kymanox site in King of Prussia, Pennsylvania and requires presence on site (≥3 days/week).

Responsibilities include (but are not limited to):

Collaborate with project-specific project managers and technical leads to coordinate laboratory activities in support of test method development, test method validation, and ensure design verification readiness.
Support development, documentation, and qualification of test fixtures.
Oversee test method development, planning and execution of test method validations, method documentation, and sample management
Specify, purchase, and qualify equipment necessary to augment capacity and capabilities to support future testing needs
Serve as liaison with sales, clients, and project teams to ensure projects are aligned with laboratory capabilities and resources
Manage and coordinate personnel and equipment resources to support testing activities based on project timelines
Work with Quality to ensure compliance with Quality Management System including managing and evaluating deviations and coordinating testing document reviews.
Establish best practices for testing to ensure efficiency during testing and delivery of high-quality testing data
Develop and deliver strategic initiatives for improving lab and testing functionality and efficiency
Work with testing services to build and maintain laboratory master schedule
Review and approve testing documentation including testing plans, method validation protocols and reports, and testing reports.
Support statistical analysis and act as Data Reviewer of data collected during testing.
Creating and/or updating applicable Standard Operating Procedures that govern laboratory workflows.
Manage 3-5 laboratory engineers/operators as direct reports.

Educational Background:

Minimum of Bachelor’s degree in scientific, engineering, or other technical discipline from an accredited institution or equivalent.

Experience:

5+ years of experience in testing of medical devices, combination products, pharmaceuticals, and/or biotech/biologics is required.
5+ years of experience in developing and validating functional test methods. Experience designing, executing, and analyzing test method validation studies is required.
1+ years of project management experience preferred.
2+ years of personnel management experience preferred.
Familiarity with GxP requirements, FDA/ICH guidance, ISO standards, and USP is required.
Experience working hands-on in a laboratory setting is required.
Specific experience with Design Verification activities is preferred.
Experience using Minitab statistical software for method validation and data analysis is preferred.
Experience working as a service provider is preferred.

Desired Aptitude and Skill Set:

Highly organized and excellent attention to detail
Ability to follow-up on assignments without reminders
Strong analytical skills
Fast learner and adaptable to change
Ability to work with cross-functional teams, both within Kymanox and with clients or suppliers
Strong planning and management skills
Adept at proactive and creative problem solving
Demonstrates strong accountability
Solution-oriented, eye for improvement and efficiency gains
Pleasant and positive communication style
Strong customer-service aptitude
Thrive in a fast paced, growing, and dynamic work environment
Ability to follow procedures when they exist
Appreciation for variety
Technical writing skills (content and format)
Adept at Microsoft Office suite of products
Natural ability to exercise confidentiality and discretion with sensitive information

Travel:

Up to 10% travel domestically (primarily) and internationally may be necessary to support client work.

Career Development:

The position may evolve over time and responsibilities will be added. Since Kymanox is a growing company, there will be ample opportunities for advancement – both within the currently defined role, with other groups, and roles to be defined in the future.

Compensation:

Base compensation will be commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for bonus program after 6 months of outstanding work.

Benefits:

Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.

About Kymanox:

Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC and we have offices in Pennsylvania along with Boston.

To learn more about our company, please visit our website: Life Science Solutions | Kymanox

Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.

Average salary estimate

$110000 / YEARLY (est.)

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$90000K

$130000K

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What You Should Know About Test Engineering Lead, Kymanox

Are you ready to take the lead in a transformative role as a Test Engineering Lead at Kymanox? Located in King of Prussia, Pennsylvania, this position offers a fantastic opportunity to make a significant impact in the medical device and combination product testing arena. At Kymanox, you won’t just be another cog in the wheel; you’ll be in a position where your influence and innovative thinking can truly shine. As a Test Engineering Lead, you'll oversee both GxP and non-GxP projects, focusing particularly on the development and validation of physical test methods. This is a multifaceted role, where your responsibilities will include collaborating with project managers to coordinate lab activities, ensuring design verification readiness, and leading a team of laboratory engineers. Your strategic mindset will help establish best practices that drive efficiency, ensuring we provide high-quality testing results. You’ll also manage the purchase and qualification of equipment necessary for our testing needs. If you're passionate about making a difference in the life sciences field and enjoy working in a dynamic team centered around solving problems, Kymanox is right for you. Plus, you'll have ample opportunities for career advancement as we continue to grow and take on exciting new projects. Join us and be at the forefront of delivering modern medicines that enhance and save patient lives!

Frequently Asked Questions (FAQs) for Test Engineering Lead Role at Kymanox

What are the primary responsibilities of a Test Engineering Lead at Kymanox?

As a Test Engineering Lead at Kymanox, your primary responsibilities include overseeing the strategic coordination of GxP and non-GxP projects, specifically focusing on test method development and validation. You will collaborate with project managers, manage laboratory resources, and ensure compliance with quality standards, all while leading a team that strives to achieve the highest testing accuracy.