Senior Manufacturing Engineer

Integra LifeSciences • Prospect, CT

7d • $71,000 - $98,000

About The Position

Plans and designs manufacturing processes and methods to support medical device component manufacturing and improve production efficiency. The role supports operational goals by analyzing and managing changes to existing processes, machining steps, product drawings, specifications, standards, and tooling. It documents existing systems and equipment functions, develops and performs testing to confirm equipment performs its intended functions, and works with technicians, machinists, and management to document existing methods and tools. The engineer serves as the subject matter expert for assigned product lines, supports audit activities, and provides first response to shop-floor alerts.

The position works with Harmonic materials and machining processes, develops engineering prototypes and tests, leads and contributes to engineering teams, and supports production, regulatory, quality, marketing, supplier, and cross-functional activities. It authors specifications, test protocols, qualification protocols and reports, and validation documentation. The role also leads projects involving transfers, new product introductions, and capital expenditure, and is expected to travel 10%.

Requirements

• Bachelor of Science in Mechanical Engineering or an equivalent discipline with at least 8 years of related engineering experience, or a master's degree in a relevant discipline with at least 5 years of related engineering experience.
• Ability to solve complex problems and influence and communicate across functional groups and organizational levels.
• Excellent verbal and written communication skills.
• Proficiency with department development tools, such as SolidWorks and AutoCAD.
• Knowledge of Engineering Change Order systems.
• Knowledge of engineering test protocols.
• Ability to lead teams through complex projects.
• Knowledge of GMPs, ISO 13485 Design Control, and medical-device manufacturing process IQ/OQ/PQ qualifications.
• Ability to make presentations at company meetings.
• Ability to communicate effectively with internal and external personnel.
• Ability to provide departmental technical leadership.
• Ability to review and analyze engineering reports.
• Strong computer skills, including experience with MRP/ERP systems.
• Ability to repeatedly sit, listen, speak, move throughout the building, use a computer keyboard, and access all company areas.
• May periodically need to lift and/or move up to 25 pounds.

Nice To Haves

• Medical device experience.

Responsibilities

• Work with Harmonic materials and medical-device manufacturing processes; learn product lines and machining steps and build institutional knowledge.
• Analyze machining data and draw cause-and-effect conclusions.
• Design and develop engineering prototypes of new products and processes with other engineering personnel.
• Execute tactical implementation of strategic plans.
• Prepare cost and time estimates for engineering work and project schedules.
• Instruct engineers and technical support staff on engineering test and build requirements.
• Lead and participate in teams developing engineering designs and tests.
• Write engineering test protocols for component parts and integrated systems.
• Develop and write specifications for components, systems, products, processes, packaging, and labeling.
• Author qualification protocols and reports, including IQ/OQ/PQ, and PV documentation.
• Work with engineering personnel to resolve production problems and implement changes as needed.
• Coordinate with Regulatory Affairs/Quality Assurance and Documentation to establish regulatory and quality documentation procedures.
• Work with Marketing and cross-functional teams to define and introduce new products.
• Work directly with finished-goods suppliers on product and process development, release, and sustaining activities.
• Lead and implement projects for transfers, new product introductions, and capital expenditure.
• Serve as the subject matter expert for assigned product lines, support audits, and provide first response to shop-floor alerts.
• Use department development tools and MRP/ERP systems as required.
• Travel as required; the position is expected to require 10% travel.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) savings plan
• Employees may be eligible for bonus, commission, equity, or other variable compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior