Who are we:

Bunnell Inc., is a leading ventilator manufacturer for premature infants. We provide inspired infant care with our revolutionary Life Pulse® Ventilator, the first high-frequency ventilator ever approved by the U.S. Food and Drug Administration (FDA) for clinical use (1988).

Job Summary:

Will be responsible for supporting our existing products through design and manufacturing improvements, validation, and verification of new components, writing production procedures, investigation of field failures, writing technical documents, working with vendors to improve quality, and documentation of changes in accordance with regulatory agencies.

Job Responsibilities:

• Designing, implementing, maintaining, and improving manufacturing fixtures, jigs, and Medical Device products.
• Writing Validation and Verification protocols pertaining to products, fixtures, manufacturing processes and fixture maintenance.
• Responsible for released technical writing, assembly drawings, assembly instructions, engineering change orders, manuals, and test evaluations.
• Review Failure Investigation Reports as the reviewing engineer for the complaint management system.
• Work with outside vendors to ensure all designs can be manufactured to specifications at a reasonable cost, timely manner and meet incoming inspection quality standards as required per FDA GMPs and Bunnell, Inc.
• Write First Article Inspection records for product components and assemblies.
• Collaborate Quality Assurance in assuring all assembly and process instructions are current.
• Initiate Engineering Change Orders and assist Document Control Technicians within the ECO process. Participates in the review and sign off of Engineering Change orders.
• Participate in the Non-conforming Material Review Board for product component and assembly rejects.
• Observe all company safety policies and practices.
• Maintain and encourage cooperative relationships with all other Bunnell employees in supporting the company mission and strategic plan.

Minimum Qualifications:

• Bachelor of Science degree (B. S.) in Manufacturing Engineering or equivalent from a four-year college or university.
• Ability to read and develop schematics and electrical drawings.
• Altium or equivalent experience desired.
• Basic programming skills.
• Understanding of electrical engineering codes and safety standards.
• Problem-solving abilities.
• Attention to detail.
• Strong organizational and communication skills.
• Analytic, creative, and business focused problem solver.
• Experience working within a formal Quality Management System.
• The ability to solve and implement solutions for electrical and mechanical issues.
• The ability to multitask.
• Excellent written and verbal communication skills.
• Team Player who is interested in a long-term commitment.

Benefits:

• 10 days Vacation
• 10 Paid Personal Absences
• Paid Holidays (in addition to Vacation Days)
• 125 Cafeteria Plan
• Up to 4% discretionary employer match to 401(k) Savings Plan
• Bunnell Employee Stock Trust (discretionary contribution of an additional 21% of total compensation once employment obligations are met)
• Health, Vision, and Dental Insurance (Bunnell pays 100% of the premium for employees and 50% of the premium for qualified dependents)
• Identity Protection Insurance
• Life-Insurance
• Long-Term Disability Insurance
• Tuition Assistance and Continuing Education