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Medical tech for diagnosis & treatment of urology, gynecology, colorectal issues

Mechanical Engineer - PLM

  • Portsmouth
  • |2 years of exp
  • |Full Time
Posted: 1 month ago
Job Location
Portsmouth
Remote Work Policy

In office

Visa Sponsorship

Not Available

RelocationAllowed
Skills
Machining
Solidworks
ISO 13485
FEA
IEC 60601
Validation
IEC 62304
GMP
Sheet metal
EU MDR
Design for Excellence
CFR 820
Analytical Methods
EU MDD
FDA’s QSR
CTQ Design and Development
Test Method Verification
Injection Molding Parts Design

About the job

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the PLM engineering team, the Mechanical Engineer is responsible

for key engineering activities to ding support to support ongoing improvements and

maintenance of the current product lines in the Laborie Portfolio. This includes aspects

including product and component design, material selection, customer and product

specification development, packaging design, and other product development activities in

support of revenue, quality, production, and cost reduction goals.

About the Role:

The Mechanical Engineer has a variety of duties and responsibilities that include

engineering, as well as other project-related activities:

• Assist in managing the product life cycle of current product lines in the Laborie

Portfolio.

• Design, implement, and deliver product changes to support sales, marketing,

production, and service.

• Maintains and updates specifications, material selections, drawings, BOMs, and

other design documentation relevant to the product as defined by the quality

system.

• Assess changes in production and the impact on the design of the product.

• Will work on the development of test setups and systems strategies which will aid

in executing design verification/validation studies.

• Aid in the creation of Product and Development Documentation in compliance with

Laborie QMS, ISO, and other applicable standards.

• Work closely with cross-functional teams to integrate the design of the system, as

well as to execute design changes.

What you Bring:

Minimum Qualifications:

• Bachelor’s degree in mechanical engineering, and a minimum of 2 years of

engineering design experience.

• Proficiency in Computer-Aided Design (CAD) software (SolidWorks)

• Working knowledge of SolidWorks PDM is an asset.

• Proven experience in the design and development of the product and the

change management process (if the medical domain is an asset)

• Good understanding / Familiarity with engineering concepts including

design for excellence, FEA, CTQ design and development, and the

engineering change process.

• Knowledge of applicable standards/regulations such as GMP, FDA’s QSR

(CFR 820), IEC 60601 and/or IEC 62304 EU MDD/EU MDR, and ISO 13485,

and understanding of test method verification, validation, and analytical

methods.

• Strong analytical and problem-solving skills

• Excellent attention to detail and a commitment to quality

• Excellent communication skills, collaboration skills, ability to work on

multiple projects concurrently, and technical aptitude “hands-on” approach

to engineering.

Preferred Qualifications:

• Medical device experience is strongly preferred.

• Machining, Sheet Metal & Injection Molding Parts design experience is

Required.

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

  • Paid time off and paid volunteer time
  • Medical, Dental, Vision
  • Pension Plan
  • Parental Leave and Adoption Services
  • Health and Wellness Programs and Events

Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

About the company

Laborie Medical Technologies company logo
Medical tech for diagnosis & treatment of urology, gynecology, colorectal issues501-1000 Employees
Company Location
Portsmouth
Company Size
501-1000
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