Operations Engineer

Cerapedics, Inc.•Westminster, CO

just now•$95,000 - $136,000•Onsite

About The Position

Cerapedics is a global, commercial-stage orthopedics company dedicated to redefining the path to bone repair. The Operations Engineer will contribute to this mission by supporting the processes, materials, equipment, and systems that enable the consistent production of innovative bone repair technologies. Working on the Technical Operations team, this role involves collaborating with cross-functional teams and suppliers, evaluating material and process changes, coordinating testing, analyzing technical data, and driving projects through the change control process. The position objectives include ensuring changes meet FDA, BSI, and quality system requirements, monitoring external standard changes, supporting the Engineering Change Control Process, assessing changes with stakeholders, improving processes for supply continuity, participating in change control reviews, communicating project status and risk analysis, evaluating changes, executing qualification activities, and completing documentation.

Requirements

Communicate succinctly, clearly and accurately in both verbal and written communications.
Able to create engineering reports detailing the qualifications of changes.
Experience with orthopedics or spinal medical devices is highly desirable.
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 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

Advanced degree or MBA preferred.

Responsibilities

Ensuring that any changes (e.g., raw materials, regulations, equipment, process) meet requirements (e.g., FDA, BSI, quality systems).
Ensuring changes including raw materials from vendors, processes, equipment change, etc. meet requirements in accordance with internal procedures.
Monitoring external standard changes in regulations and standards and ensuring that all work is done to ensure that products are compliant.
Supporting the Engineering Change Control Process, ensuring adequate assessment of changes in collaboration with key stakeholders.
Helping to improve key processes to ensure continuity of supply.
Actively participating in management of appropriate engineering change controls and reviews.
Making an impact on proposed solutions on operational processes and procedures.
Promptly and accurately communicating project status, risk analysis, and risk mitigation plans.
Effectively answering questions in detail and producing clear and concise summaries for projects to the leadership/management team.
Evaluating changes and executing appropriate qualification activities.
Ensuring that the appropriate documentation is completed in accordance with the quality system.