Novair USA Corp is a diversified manufacturing company with its headquarters and production facility located in North Tonawanda, NY USA. Novair USA operates as a fully owned subsidiary of Novair Groupe, a global leader in the manufacturing of oxygen and nitrogen generating systems for industrial and medical applications.
The Engineering Manager is responsible for managing and directing the entire engineering team, planning/coordinating projects, product design, and research and development of existing and new products.
Duties include, but are not limited to:
- Ensuring efficient and accurate flow of custom projects through the engineering department. Ensure custom jobs are designed in accordance too sales/customer specifications. Provide input for project feasibility during early stages of contract proposal.
- Ensuring production team has adequate drawing packages, work instructions, schematics, P&IDs for all custom and standard product line catalog.
- Managing the ECN (Engineering Chance Notice) System and PDM (Product Data Management System) software to ensure that only the most current and correct revisions of drawings, schematics, work instructions, etc. are accessible to all other departments.
- Managing the engineering team to ensure all ISO 13485 Design procedures are followed to ensure ISO compliance. Continuous improvement of design process to improve operation workflow.
- Lead Research and Development projects that produce new product designs, processes, product improvement, product cost savings.
- Managing yearly Engineering/R&D budget based on company vision, project proposals, continuous improvement, etc.
- Leading engineering team to ensure department is capable of being liaison for Sales and Production departments. Make certain Engineering can support sales to ensure projects are properly spec’d, quoted/priced, and feasible for completion in adherence to any applicable standards. Ensure the department can provide production floor with support for understanding/interpreting drawing packages, schematics, product specifications, and proper building procedures.
- Managing accurate/informative product information such specification sheets, standard product general arrangement drawings, product operation manuals, product (PLC) programs. Ensuring only accurate revision is accessible to the company/customer.
- Managing engineering team through FDA 510K submission for multiple product lines to gain medical device clearance. Leading team in the creation of ‘Design History Files’ for these lines in preparation for 510K submission. Includes identifying consumer user needs, design inputs/outputs, validating/verifying product design, creatin risk assessments & design traceability matrix files.
- Ensuring ‘Design History Files’ are continuous monitored and updated in adherence with ISO 13485 and 21 CFR 820 in preparation for ISO and FDA inspection audits. Responsible for providing upper management with recommendations when re-submissions or potential change notices are required.
- Continuous monitoring of engineering team to ensure the department has adequate resources to complete all tasks accurately and efficiently. Continuously coaching and training team members.
- Provide constructive and timely performance evaluations.
- Recruit, interview, hire, and train new engineering staff.
- Ability to multi-task and meet deadlines. Great Communication and team working skills.
- Relationship Builder. Problem solver. Ability to work with a diverse group. Positive Attitude.
- Works well individually. Follows policies and procedures. Embrace new ideas and change. Follow core
- values. Mutual trust and respect for all. Consistency of purpose and process. Ethical in
- everything we do. Customer focus.
The ideal candidate will have the following qualifications. Exceptions can made on a case-by-case basis.
- Minimum of 5+ years of engineering experience in a similar field. Ideally, in design/R&D engineering in a manufacturing, or job shop production environment.
- Minimum of 3+ years of management experience having multiple direct reports.
- Experience with medical devices or in the medical device industry. Ideally direct experience with FDA 510K submissions, ISO 1845, or 21 CFR 820 Quality Management Systems.
- Experience with PSA equipment, air compressors, vacuum systems, a strong positive.
- Organizational skills for keeping track of employees, budgets, and schedules simultaneously.
- Excellent communication skills for overseeing staff and working with other management
- Strong supervisory and leadership skills.
- Strong analytical and problem-solving skills.
- Excellent time management skills with proven ability to meet deadlines.
- Detailed-oriented with the ability to catch minor errors that could result in major
- Implementing lean/six sigma concepts.
- 3D modeling. SolidWorks preferred, but not required. Must be fluent in 3D software to ensure
- engineering team can be proficient.
- 2D CAD for schematic generation (AutoCAD, or equivalent).
- Ability to interpret, produce, and teach others technical blueprints, assembly drawings, electrical schematics, P&IDs, etc.
- Demonstrated integrity and ethical standards.
- Managing time effectively and adapting quickly to changing priorities.
- Team player who works productively with a wide range of people.
- Comfortable in a fast-paced environment.
- Effective listening, verbal, and written communication skills.
- Knowledge of Microsoft Office Suite.