Senior Manufacturing Engineer

INTEGRA LIFESCIENCES CORP; Prospect (CT); On-site; USD 71,000 - 98,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Savings Plan

Job summary

Integra LifeSciences is seeking a seasoned Mechanical Engineer to design and optimize manufacturing processes for medical device components. The role requires leading engineering designs, prototyping, and testing, while guiding cross-functional teams through complex projects.

Ideal candidates have a strong background in GMPs, ISO 13485 Design Control, and IQ/OQ/PQ qualifications, with proven ability to drive efficiency and regulatory-compliant engineering changes in a fast-paced environment.

Qualifications

• BS in Mechanical Engineering or equivalent with 8+ years of related eng experience (MS with 5+ years).
• Ability to solve complex problems and communicate across all functional groups and levels.
• Excellent verbal and written communication skills.
• Medical device experience is desired; knowledge of GMPs, ISO 13485 Design Control, and related IQ/OQ/PQ qualifications.

Responsibilities

• Plans and designs manufacturing processes and methods for medical device components.
• Analyzes data and acts as SME; supports audits and shop floor change control.
• Designs and prototypes new products/processes with engineering team.
• Prepares cost and time estimates for projects and schedules.
• Writes engineering test protocols and qualification reports (IQ/OQ/PQ, PV).
• Leads and collaborates on transfers, new product introductions, and CapEx projects.

Skills

B.S. in Mechanical Eng

MS in related field

8+ years engineering experience

Problem solving

Excellent verbal & written comms

Medical device exp. desired

Development tools: SolidWorks

Development tools: AutoCAD

Engineering Change Order System

Lead teams on complex projects

GMPs / ISO 13485 knowledge

Regulatory documentation/ASQ

Education

B.S. in Mechanical Engineering

M.S. in relevant discipline

Tools

SolidWorks

AutoCAD

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

• 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.

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.

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

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

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, and group legal insurance, and 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. This site is governed solely by applicable U.S. laws and governmental regulations.

If you'd like more information on your rights under the law, please see the following notices: 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].

Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.