Mechanical Film Manufacturing Engineer III

The Opportunity

Quidel Ortho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as one Quidel Ortho we are seeking a Mechanical Film Manufacturing Engineer III to work in our manufacturing facility in Rochester, NY. The Mechanical Film Manufacturing Engineer III will provide engineering oversight of film coating equipment and supporting systems to effectively and efficiently maintain and reliably operate the manufacturing equipment on site. This role will have a strong focus on troubleshooting and managing mechanical systems and components throughout their lifecycle including repairs, replacements, and upgrades.

This position involves collaboration with various departments to ensure product compliance and continuity, to manage supply chain risks, and to validate components all while upholding the companies core values in interactions with team members and reporting to the Engineering Manager. A successful candidate will play a vital role in the overall success of operations. This position also requires system and process assessment, control of operating and maintenance documentation including performance metrics, attainment of productivity and cost objectives in daily operation, and assisting in maintenance of all equipment as needed in assigned areas and field.

This position will continuously assess the general condition and validated readiness of critical assets required to deliver high quality, safe, compliant, cost effective equipment processes without interruption.

This position is in Rochester, NY.

• 40% Support Maintenance and Operations with troubleshooting and resolving Mechanical and air system issues on current process equipment.

• 20% Lead or support large capital projects for equipment upgrades or replacements as required.

• 20% Identify and develop improvements to maximize uptime while reducing maintenance costs and improving reliability, quality, productivity, and safety.

• 10% Author and revise controlled manufacturing documentation such as preventative maintenance and standard operating procedure documents per ISO
  9000 standards.

• 10% Develop and maintain effective lines of communication across departments to achieve plant maintenance and reliability goals.

• Prepare reports, summaries, and Capital Appropriation Request (CAR) protocols.

• Exercise independent judgement that leads to overall company objectives with long-term impact on program schedules.

• Compliance with local, state, and federal regulatory bodies including FDA, ISO, EPA, OSHA, DEP and DEA.

• Initiate, facilitate, and participate and in Lean activities including 5S and Kaizen events.

• Flexibility in work schedule along with off hours support as necessary.

• Personal Protective Equipment (PPE) as required by work area.

• Perform other work-related duties as assigned (Last bullet required in North America).

Internal Customers:
Manufacturing Operations Supervisors and Managers, Cell Leaders, Site Administrative Support Personnel, Quality, Engineering, Operations and Maintenance team members.

External Customers:
Automation vendors, suppliers.

• BS or MS in Mechanical Engineering or Mechanical Engineering Technology

• 5 years of engineering experience in manufacturing.

• Strong mechanical aptitude with troubleshooting experience.

• Strong verbal and written communication.

• Ability to plan, analyze, review, and implement assignments without appreciable guidance.

• Ability to manage competing priorities in a results-driven environment.

• Ability to lead teams and meet project deadlines.

• Adept in "Good Manufacturing Practices" (GMP).

• Adept in Microsoft Office tools (e.g. Word, Excel, PowerPoint, etc.).

• Experience working in an FDA medical device manufacturing facility with associated FDA and ISO regulations.

• Experience with motor drive systems, process controls systems, manufacturing equipment and vision systems.

• Working around moving machinery.

• Protective equipment required (Ear protection, gloves, eyewear, safety shoes).

• No strenuous physical activity is required, though occasional light lifting may be involved.

• Approximately 30% of the time is spent in meetings, collaborating with the team, or talking on the…