Senior Operations Engineer

Cerapedics•Westminster, CO

7d•$133,000 - $167,000•Onsite

About The Position

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. OVERVIEW Healing lives through bone repair – this mission is what inspires us every day. If that is inspiring to you as well, consider joining us as a Senior Operations Engineer in our Westminster office. In this role, you will contribute to our mission through helping refine and manage Change Control Process and ensure we integrate key stakeholders across various functions such as external suppliers, R&D, manufacturing, quality, etc. As a Senior Operations Engineer working on the Technical Operations team, you will be empowered through meaningful work and career development to lead and manage the lifecycle of challenging cross-functional projects and determine necessary testing plans to ensure product Conformance. A typical day will include- understanding best engineering practices for evaluating and assessing raw material, equipment, process, and test method changes for technical, risk and regulatory impact. POSITION OBJECTIVES: Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems). Manage all critical external vendor partners so that we can proactively manage changes Ensure all internal processes are implemented, and any changes including raw materials from non-critical vendors, processes, equipment change, etc. meet requirements. Monitor external standard changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant. Drive the Engineering Change Control Process. Ensure that we adequately assess changes in collaboration with key stakeholders. Help improve key processes to ensure continuity of supply. Identify and lead process improvement initiatives that improve engineering and cross functional teams’ efficiencies, optimizing value and delivery. Through collaboration, generate high-quality, cost-effective solutions in compressed periods of time. Actively participate in management of appropriate engineering change controls and reviews. Makes impact on proposed solutions on operational processes and procedures. Promptly and accurately communicate project status, risk analysis, and risk mitigation plans. Effectively answer questions in detail and produce clear and concise summaries for projects to the leadership/management team. Evaluate changes and execute appropriate qualification activities. Ensure that the appropriate documentation is completed in accordance with the quality system.

Requirements

Communicate succinctly, clearly and accurately in both verbal and written communications.
Able to create engineering reports detailing the qualifications of changes.
Aptitude to develop technical expertise in new therapeutic areas.
Strong analytical and problem-solving skills.
Ability to work effectively in a cross-functional environment.
Must be self-motivated, assertive and able to approach with a positive ‘can-do’ attitude.
Ability to cultivate and maintain relationships with thought leaders and to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from thought-leaders.
Knowledge of FDA and ISO guidelines for medical devices.
Bachelor’s degree in engineering or Scientific discipline or an equivalent combination of education and work experience.
Minimum of 7 years of experience with progressively increasing responsibility or complexity.
Minimum of 3 years in medical device, biomedical, or pharmaceutical industries.

Nice To Haves

Experience with orthopedics or spinal medical devices is highly desirable.
Advanced degree or MBA preferred.

Responsibilities

Responsible for ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems).
Manage all critical external vendor partners so that we can proactively manage changes
Ensure all internal processes are implemented, and any changes including raw materials from non-critical vendors, processes, equipment change, etc. meet requirements.
Monitor external standard changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant.
Drive the Engineering Change Control Process.
Ensure that we adequately assess changes in collaboration with key stakeholders.
Help improve key processes to ensure continuity of supply.
Identify and lead process improvement initiatives that improve engineering and cross functional teams’ efficiencies, optimizing value and delivery.
Through collaboration, generate high-quality, cost-effective solutions in compressed periods of time.
Actively participate in management of appropriate engineering change controls and reviews.
Makes impact on proposed solutions on operational processes and procedures.
Promptly and accurately communicate project status, risk analysis, and risk mitigation plans.
Effectively answer questions in detail and produce clear and concise summaries for projects to the leadership/management team.
Evaluate changes and execute appropriate qualification activities.
Ensure that the appropriate documentation is completed in accordance with the quality system.