Product Evaluations Engineer III

Are you a mechanical maestro ready to unleash your expertise? At BDC Laboratories, we invite you to immerse yourself in an exhilarating role as a Full-Time Product Evaluations Engineer III onsite in Wheat Ridge, CO. This isn’t just any gig; it’s an opportunity to innovate and solve real-world problems, all while collaborating with a vibrant team that values customer satisfaction above all.

As you dive into engaging projects that drive the biotech industry forward, you'll enjoy a competitive salary ranging from $95,000 to $112,000. Here, your ingenuity and keen eye for excellence will be recognized, not just encouraged. The thrill of working in a dynamic, energetic environment awaits you!

You will be provided great benefits such as Medical, Dental, Vision, 401(k), Health Savings Account, and Paid Time Off. Don’t miss the chance to be at the forefront of biotechnology, where every day is a new adventure. Elevate your career with us today!

Let us introduce ourselves

Biomedical Device Consultants & Laboratories () is a fast-growing company that offers comprehensive medical device testing services, designs verification test equipment, and produces silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding.

Your day to day as a Product Evaluations Engineer III

As a Full-Time Product Evaluations Engineer III at BDC Laboratories, your mission is to ensure that every piece of equipment meets the rigorous demands of our biotech studies. You’ll assess the suitability of equipment for data acquisition, ensuring compliance with protocol specifications. Your expertise will keep our laboratory inspection-ready, as you guarantee all equipment is designed for optimal performance, adequately cleaned, and meticulously maintained. You'll lead the way in establishing innovative test methods, preparing meticulous protocols, and maintaining a contamination-free environment.

Each data entry you record will enhance the integrity of our research, as you diligently verify and analyze experimental data. Additionally, you will play a key role in supporting our Quality Management System and participating in audits, all while setting an exemplary standard for your colleagues. This position is not just about maintaining excellence; it's about driving innovation in a fun, high-performance culture.

Requirements for this Product Evaluations Engineer III job

To thrive as a Full-Time Product Evaluations Engineer III at BDC Laboratories, you’ll need a robust toolkit of skills and experiences. A minimum of a Bachelor’s Degree in engineering or a science-based field, coupled with relevant years of experience, establishes your foundational expertise. Familiarity with quality system requirements like ISO 17025 and 21 CFR Part 58 is preferred, while knowledge of ISO 13485 and 21 CFR Part 820 will set you apart. Your analytical and problem-solving prowess will be crucial, allowing you to perform statistical analyses and interpret technical regulations effectively. Strong verbal and written communication skills are essential for drafting clear protocols and presenting information to both managers and team members.

Additionally, your ability to mentor and manage fellow engineers will contribute to a dynamic and collaborative team environment. Embrace this opportunity to lead with integrity in a forward-thinking biotech space!

Knowledge and skills required for the position are :

• Minimum of a Bachelor’s Degree in an engineering field and 4 years of experience; or minimum of a Master’s Degree in an engineering field and 2 years of experience; or minimum of a Bachelor’s Degree in a science-based field and 6 years of relevant experience; or an Associate Degree with a minimum of 10 years of relevant experience.
• Understanding of quality system requirements including ISO 17025 and 21 CFR part 58 is preferred. Experience in 21 CFR Part 820 and Part 11, ISO 13485 and other relevant international standards desirable.
• Must be organized with excellent analytical and problem-solving abilities and the ability to perform and report basic statistical analyses.
• Ability to read analyze and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members. Ability to effectively draft protocols and reports.
• Ability to define problems, collect data, establish facts and draw valid final conclusions.
• Strong verbal and writing skills and good interpersonal and leadership skills.
• Proficiency with a Windows environment(Word and Excel) required.
• Experience managing other engineers.

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