Senior Manufacturing Engineer

Integra LifeSciences; Prospect (CT); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Job summary

Integra LifeSciences is seeking an experienced Mechanical Engineer to design manufacturing processes and tools for medical device components. You will analyze existing methods, document equipment functions, and support audits as the SME for assigned product lines.

Responsibilities include leading engineering prototypes, developing test protocols, and coordinating with cross-functional teams to implement new products and transfers, while ensuring GMP and quality standards are met.

Qualifications

• BS in Mechanical Engineering or equivalent with 8+ years of related experience or MS with 5+ years.
• Ability to solve complex problems and communicate across all teams.
• Medical device experience is desirable.
• Proficiency with engineering tools (SolidWorks, AutoCAD) used by the dept.
• Knowledge of GMPs, ISO 13485 Design Control, and IQ/OQ/PQ qualifications.

Responsibilities

• Plan and design manufacturing processes and tooling for medical device components.
• Lead teams on complex engineering projects and product transfers.
• Prepare cost and time estimates for engineering and project schedules.
• Write protocols for testing and qualification of components and systems.
• Collaborate with RA/QA and Marketing on new product introductions.

Skills

Problem solving

Cross-functional communication

Leadership

Verbal and written communication

Education

BS in Mechanical Engineering or equivalent

MS in relevant discipline

Tools

SolidWorks

AutoCAD

MRP/ERP systems

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary Description

Plans and designs manufacturing processes as well as design methods to support medical device component manufacturing and improve efficiency in production. This position supports operation’s goals by analyzing and managing change of existing processes, machining steps, product related drawings, specifications, standards, and tooling required in the manufacture of components. Duties will include documenting existing systems and equipment functions, writing and performing testing of equipment to perform its intended functions, and working with senior staff of technicians, machinists, and management to document existing methods and tools. This position acts as the subject matter expert (SME) for assigned product lines which includes supporting audit activities and first response for shop floor alerts.

Essential Duties And Responsibilities

• Works with Harmonic materials for the manufacture of medical devices. Knowledge of machining and ability to analyze data and draw cause and effect conclusions is part of responsibilities. Learn the product mix and machining steps and build institutional knowledge.
• Designs and works with other engineering personnel to create and develop engineering prototypes of new products/processes.
• Executes tactical implementation of strategic plans.
• Prepares cost and time estimates for engineering and project schedules.
• Instructs engineers and technical support staff on engineering test and build requirements.
• Works as a team leader (and as a team member when required) in the development of engineering designs and tests.
• Writes engineering test protocols for testing of component parts and integrated systems.
• Develops and writes specifications for components/systems, product, processes and packaging/labeling.
• Authors various type of qualification protocols and reports (IQ/OQ/PQ) and PV.
• Works with engineering personnel on production problems and changes as necessary.
• Works with RA/QA and Documentation departments to establish proper regulatory and quality documentation procedures.
• Works with Marketing and cross-functional teams to define and introduce new products.
• Works directly with finish goods suppliers in all aspects of product/process development, release and sustaining activities.
• Leads and implements projects for transfers, new product introductions and CapEx spend.

Desired Minimum Qualifications

The requirements listed below are representative of the knowledge, skill and/or ability required for this position.

Education & Experience

• BS degree in Mechanical Engineering or Equivalent discipline with at least eight (8) years of related engineering experience; or MS in relevant discipline with at least five (5) years of related engineering experience.
• Ability to effectively solve complex problems and ability to influence and communicate across all functional groups and levels.
• Excellent verbal and written communication skills.
• Medical device experience is desired.
• Proficiency with development tools (e.g. SolidWorks, autocad) used by the department.
• Knowledge of Engineering Change Order System.
• Knowledge of engineering test protocols.
• Ability to lead teams through complex projects.
• Knowledge of GMPs, ISO 13485 Design Control, and Manufacturing Process IQ, OQ, PQ qualifications as related to medical devices is required.
• 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.

TOOLS AND EQUIPMENT USED

Ability to utilize a telephone, fax, copier and desktop computer with finance and other typical business programs installed, including spreadsheets, word processing and MRP/ERP systems. Strong computer skills are required. Knowledge and experience with MRP/ERP systems is required.

Physical Requirements

The physical requirements listed in this section include, but are not limited to, the motor/physical abilities and skills required of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position. While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and have the mobile ability move throughout the building. Candidates must be capable of using a keyboard for computer purposes. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs. This position is expected to require 10% travel.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment. Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps and medical wastes.

Salary Pay Range

$71,000.00 - $98,000.00 USD Salary

Additional Description for Pay Transparency

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs:

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciences

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at [e-mail].