JOB DESCRIPTION: Operations Manager

General: Full-Time, Exempt Employee Classification: Professional

Reports To: Head of Operations Direct Reports: Head of Manufacturing, Facilities

Department: Operations

Location: Onsite preferred (Philomath, OR 97370); 75-80% hybrid optional Schedule/Hours: Monday - Friday, day shift (occasional nights and weekends as production schedule dictates)

Overview of Lazarus 3D: Surgeon skill and experience are the biggest determinants of patient outcomes. Unfortunately, surgeons learn by operating on patients and sometimes they make costly mistakes. Lazarus 3D’s Pre-Sure platform allows surgeons to rehearse every surgery ahead of time on a replica of their patients’ organs. This unparalleled opportunity to exercise their surgical plan on Pre-Sure is game-changing in surgical care as it can transform patient safety and outcomes. Lazarus 3D’s Skill-Sure platform delivers world class solutions to healthcare professionals interested in reducing the learning curve, innovation and adoption of new medical devices. Pre-Sure and Skill-Sure models mimic soft, realistic textures of real organs and provide a unique hands-on operative experience.

Our mission is to help doctors operate with confidence
Lazarus 3D is driven by a singular mission: to enhance patient safety and outcomes through tailored solutions that empower surgeons to operate with unwavering confidence. Our vision is ambitious yet resolute—to eradicate surgical errors, ensuring that every patient receives the best care possible.

Join us at Lazarus 3D as we redefine the boundaries of surgical precision and pave the way for a future where impeccable care is the standard.

Your Role at Lazarus 3D
In this role, you manage and supervise Operations activities as dictated by forecasted demand and order fulfillment. This includes: driving operational excellence and promoting a LEAN/Six Sigma philosophy across the organization to ensure products and processes meet quality standards; coordinating short-term project priorities within the organization and providing oversight of Operations key decisions; performing activities to meet the production schedule and project timelines (by performing tasks personally or ensuring subordinates and collaborators complete the tasks); supporting the organization in activities related to the transformation of raw materials and intermediates into high-quality intermediates and finished products in a regulated medical diagnostics environment.

Essential Job Functions:

• Supports our vision and mission: To improve patient surgical outcomes.
• Proactively promotes positive culture and commitment to customer success.
• Embrace company core values.
• Optimize resource utilization by planning and allocating labor, materials, and equipment.
• Develop and maintain an Operations program for the organization that meets or exceeds corporate goals.
• Develop and present reports on data/trending to management. Provides input to strategy to meet Operational Objectives for the organization.
• Manage day-to-day operations of the project management, manufacturing, materials management and development/improvement functions and coordinates activities to achieve corporate goals.
• Participate in Design Controls projects and ensure transition of new products from R&D into Operations.
• Drive LEAN/Six Sigma initiatives and continuous improvement projects to achieve Operational excellence and improve margins.
• Comply with Lazarus 3D’s Quality System.
• Perform tasks as assigned by supervisor/manager.

Qualifications and Critical Skills/Expertise:

• 10 years experience with Bachelors OR 5 years experience with Masters in Chemistry (polymer, preferred), Engineering or similar
• 7 years in medical device or pharma arena or complex manufacturing required
• Experience working in manufacturing under a quality system such as ISO 13485 and or 21 CFR part 820 cGMPs or GLP
• Prior experience supervising lab techs, engineers, scientists, senior scientists, project managers
• Proficient in the use of Google Suite, Project Management software and QuickBooks
• High attention to detail
• Ability to interpret CAD drawings
• Readily adapts to changes in the work environment and facilitates the adaptation of team to change; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change; delays; or unexpected events.
• Ability to read, analyze and interpret professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, and customers. Proficient in English
• Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other Knowledge and Skills:

• Basic human anatomy and medical procedures, a plus
• Six Sigma or Operational Excellence Certification preferred; Certification of prior training in cGMPs, QSR's, ISO13485 highly desirable

Equipment:

• General lab equipment
• 3D printing equipment
• Calipers

Working Environment & Physical Requirements:
Approximately 75% of responsibilities are performed in the lab, 25% in an office environment.

While performing the duties of this job, the employee must regularly:

• Experience prolonged sitting, some bending, stooping, and occasional fast walking.
• Use hand-eye coordination and manual dexterity sufficient to operate hand tools.
• Occasionally lift and/or move up to 40 pounds.
• May have exposure to biologics and chemicals.
• Requires close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Applications should be submitted via indeed. The CV and cover letter should be combined into a single document and uploaded to Indeed.

Lazarus 3D is an Equal Opportunity Employer; Employment with Lazarus 3D is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status.

Candidates must be US citizens/Permanent residents or be eligible to work in the United States.

Job Type: Full-time

Pay: $72,800.00 - $135,200.00 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• What is your experience working in an FDA regulated or ISO compliant company?

Experience:

• Manufacturing: 10 years (Required)

Work Location: Hybrid remote in Philomath, OR 97370