Operations Engineer

Cerapedics Inc.; Broomfield (CO); Presencial; USD 95.000 - 136.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental insurance

Group life insurance

401k matching

Long term disability

Target bonus

Paid time off

Descripción de la vacante

Cerapedics Inc. in Westminster, Colorado, is seeking an Operations Engineer to join our team in the Westminster office.

The role focuses on ensuring changes comply with FDA/ISO guidelines, participating in engineering change control, and maintaining supply continuity. You will collaborate across functions, communicate risk and project status clearly, and develop technical expertise in new therapeutic areas.

Formación

• Experience in medical device, biomedical, or pharmaceutical industries (2+ years).
• Strong communication and technical writing skills.
• Ability to work cross-functionally with engineering and QA.

Responsabilidades

• Ensure changes meet requirements (FDA, ISO, quality systems).
• Verify changes including raw materials, processes, equipment meet internal procedures.
• Monitor external regulatory changes and ensure compliance.
• Support Engineering Change Control; assess changes with stakeholders and improve processes.
• Participate in management of engineering change controls and propose solutions.
• Communicate project status, risk analysis, and mitigation plans to leadership with concise summaries.
• Execute qualification activities and document according to the quality system.

Conocimientos

Orthopedics experience

Cross-functional collaboration

FDA/ISO knowledge

Problem solving

Communication skills

Educación

Bachelor’s degree in engineering or scientific discipline

Advanced degree or MBA preferred

Descripción del empleo

ABOUT US

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado.

DESCRIPTION

Cerapedics is a global, commercial-stage orthopedics company that is dedicated to redefining the path to bone repair by healing bones faster and at higher rates, so all patients can get back to living their fullest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. Cerapedics has two drug-device products approved by the FDA powered by Cerapedics’ proprietary P-15 Osteogenic Cell Binding Peptide: PearlMatrix™ Bone Graft for all major lumbar interbody surgical approaches and i-FACTOR® Bone Graft for single-level anterior cervical discectomy and fusion (ACDF) in the cervical spine. Cerapedics is headquartered in Westminster, Colorado.

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.

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.

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

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.

COMPENSATION DETAILS

95000-136000 Yearly Salary

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