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 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.
POSITION OBJECTIVES: - 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.
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 or pharmaceuticals.
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.
- Needs 3-5 years of experience with progressively increasing responsibility or complexity.
- Minimum of 2 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: N/A
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: $95,000.00 - $136,000.00
Base Salary: Annually
Target Annual Bonus: 12%
This position will be posted through 11/2/2026 
