Operations Engineer

Cerapedics•Westminster, CO

10d•Onsite

About The Position

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 Operations Engineer in our Westminster office. In this role, you will contribute to our mission by supporting the processes, materials, equipment, and systems that enable the consistent production of innovation bone repair technologies that help improve patients' lives. As an Operations Engineer working on the Technical Operations team, you will be empowered through meaningful work and career development to help drive projects through our change control process. A typical day will include collaborating with cross-functional teams and suppliers, evaluating proposed material and process changes, coordinating testing activities, analyzing technical data, and driving projects through the change control process.

Requirements

Communicate succinctly, clearly and accurately in both verbal and written communications.
Able to create engineering reports detailing the qualifications of changes.
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 or pharmaceuticals.
Bachelor’s degree in engineering or Scientific discipline or an equivalent combination of education and work experience.
Needs 3-5 years of experience with progressively increasing responsibility or complexity.
Minimum of 2 years in medical device, biomedical, or pharmaceutical industries.

Nice To Haves

Experience with orthopedics or spinal medical devices is highly desirable.
Aptitude to develop technical expertise in new therapeutic areas.
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).
Ensure changes including raw materials from vendors, processes, equipment change, etc. meet requirements in accordance with internal procedures.
Monitor external standard changes in regulations and standards and ensure that we have done all the work to ensure that our products are compliant.
Support 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.
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.