ABOUT US

Cerapedics is a global, commercial-stage ortho-biologics company that aspires to transform the standard of care for bone repair, healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest life. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma and interventional procedures world-wide. Cerapedics’ product, i-FACTOR, is FDA PMA approved for cervical use in the United States. Cerapedics’ next-generation product is currently being evaluated in lumbar interbody fusion through ASPIRE, a pivotal FDA IDE study and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.

POSITION REQUIREMENTS:

• 5+ years Quality/Engineering experience; preferably medical device or other regulated industry.
• Technical and analytical skills with the ability to interpret complex data.
• Proficient in quality tools and methodologies commonly used in the medical device industry.
• Detailed knowledge of FDA, GMP, ISO 13485, EU MDD, EU MDR.
• Exceptional time management with the ability to meet regulatory and organizational deadlines.
• Strong written and verbal communication skills for diverse audiences.
• Decisive and data-driven decision-making capabilities
• Ability to influence, persuade, and motivate cross-functional teams.

EDUCATION AND PREFERRED TRAINING REQUIREMENTS:

• Bachelor’s Degree in Engineering or Engineering technology; other technical degrees may be considered.

• This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
• This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
• This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination