Design Control Specialist at Danaher Corporation

Portsmouth, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Biotechnology, Life SciencesIndustries

Requirements

Degree in Science or Engineering related subject or equivalent experience
Strong background and significant experience within the field of Medical Device Product Development/Quality/Regulatory
In-depth knowledge of regulations and standards, such as ISO 13485, ISO 14971, FDA 21 CFR 820, and the EU Medical Device Regulation (MDR)
Strong understanding of the overall design control process, including design inputs, outputs, verification, and validation
Excellent written and verbal communication skills
Ability to travel – Limited travel to other Cytiva sites within UK and Europe

Responsibilities

Establish and maintain the Design Control process for devices, filters and associated separation systems for global Pall Medical applications within the guidelines of an ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP and the EU Medical Device Regulation (MDR)
Ensure that all Pall Medical design activities conform to Cytiva Design Control procedures throughout the product lifecycle, within the guidelines of ISO 13485 and ISO 9001 compliant Quality Management System, and where relevant FDA 21 CFR 820, MDSAP, and the EU Medical Device Regulation (MDR)
Provide guidance to the Pall Medical Research and Development and Product Engineering teams in the preparation of design control documentation throughout the product lifecycle, including the preparation of Design History Files (DHFs)
Lead a cross functional team in conducting product risk analysis to ISO 14971 and implementation of risk management strategies throughout the product lifecycle of Pall Medical products
Work with cross functional technical teams to develop protocols for the verification and validation (V&V) testing of prototypes and finished products
Contribute to the development and improvement of design and development processes to enhance efficiency and ensure product quality

Skills

Design Control

ISO 13485

ISO 9001

FDA 21 CFR 820

MDSAP

EU MDR

Quality Management System

Medical Devices

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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