Senior Operations Engineer at Cerapedics, Inc.

Broomfield, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Jul, 26

Salary

167000.0

Posted On

02 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Communication, Analytical Skills, Problem-Solving Skills, Technical Expertise, Cross-Functional Collaboration, Engineering Change Control, Regulatory Compliance, Process Improvement, Project Management, Risk Analysis, Documentation, Quality Systems, Vendor Management, Medical Device Knowledge, ISO Guidelines, FDA Guidelines

Industry

Biotechnology Research

Description

Description 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. 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 POSITION 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. EDUCATION AND PREFERRED TRAINING REQUIREMENTS: Bachelor’s degree in engineering or Scientific discipline or an equivalent combination of education and work experience. Advanced degree or MBA preferred. Minimum of 7 years of experience with progressively increasing responsibility or complexity. Minimum of 3 years in medical device, biomedical, or pharmaceutical industries. WORK CONDITION/PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made when requested by the employee to enable individuals with disabilities to perform the essential functions 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. TRAVEL REQUIREMENTS: About 4-5 trips a year each of which will last 2-3 days, to meet with key suppliers and business partners. BENEFITS/COMPENSATION (including, but not limited to): Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off. SALARY RANGE: $133,000 - $167,000 Base Salary: Annually Target Annual Bonus: Up to 15 % This position will be posted through April 30, 2026 EEO STATEMENT: Cerapedics is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Responsibilities

The Senior Operations Engineer will manage the Change Control Process and ensure compliance with FDA and quality system requirements. This role involves collaborating with various stakeholders to assess changes and improve processes for product conformance.