Senior Product Development / Manufacturing Systems Engineer

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :

Manufacturing and Production

Education Level :

Bachelor of Business Administration

Address 1 :

Western Europe,--Stuttgart,Stuttgart,

Key Skills :

DHF, DMR, FDA, Medical Devices, Research and Development

Salary :


Date Posted :

15 May, 2017

Company Name :

Lawrence Harvey

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



This position will be within the R&D Department but includes interfacing with R&D,
Manufacturing, Process Validation and External Suppliers.
Reporting directly to the Project Team Lead the successful candidate will have the
responsibility for leading a team of 4 engineers to produce the necessary documentation
to complete Design Transfer of already designed products, including:
* Develop Component Specifications and Associated First Article Inspection Plans
for all Purchased Components
* Develop Material Specifications for Manufacturing Materials.
* Develop Specifications for Part Assembled Components.
* Develop Specifications for all in-house and externally produced labels (excluding

Key Skills & Actions Required
* Develop Component tolerances in agreement with R&D and Suppliers
* Tolerance Stack Up Calculations for sub-assemblies
* Perform and lead project activities including dFMEA, pFMEA, DoE, SPC, etc.
* Specify Process Validation Requirements
* Test Method Development
* Creation of Documentation suitable for the Design History File and Device
Master Record

Education & Training & Demonstrable Skills
* A minimum of a four year college degree in engineering or science.
* Minimum of five or more years of demonstrated success in product design and
development engineering roles with increasing responsibility in an ISO 13485
and/or FDA regulated medical device product development environment, with
the following demonstrable success:
* Demonstrable success in transferring new product development projects from
design to manufacturing and to external suppliers.
* Strong interpersonal communication skills and presentation skills
* Strong client centered attitude and maximum flexibility in a rapidly changing
* Lean Six-Sigma experience - ideally Green Belt or Black Belt accreditation.

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



Phone No. :

0203 327 3072

Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

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