Design Control and Risk Management Compliance Engineer

Overview:

TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Title: Design Control and Risk Management Compliance Engineer
Location: Cambridge, UK
Duration: 12 Months
WorkType : Onsite

Job Description:

This position is in the Biotherapeutics Pharmaceutical Research and Development (Drug Product Design and Development) located in Cambridge, UK.
The incumbent will provide design control and risk management subject matter expertise to medical device combination product development programmes throughout the product lifecycle.
This will involve ensuring consistent implementation of applicable processes and standards across the portfolio, in addition to the facilitation and documentation of specific design control and risk management activities, whilst interacting with cross functional development teams at all levels of the organisation.

Position Responsibilities

Lead design control and risk management activities for medical device combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
Support and facilitation of effective design control and risk management activities internally, at external design companies, and at client manufacturing facilities/CMOs related to assigned projects.
Generation, approval, and retention of client design control and risk management documentation ensuring that quality and regulatory requirements are satisfied.
Ensure medical device combination product design control and risk management activities are compliant with quality and regulatory standards, both internal and external.
Provide input and support to design validation including, but not limited to, use-related risk assessments.
Support the generation of all regulatory submission data and content for assigned medical device combination product projects.
Support internal and external audits of the Biotherapeutics Pharmaceutical Research and Development Quality Management Systems.

Organizational Relationships

Key groups and stakeholders the position interacts with:

Device development teams – Drug Product leads, packaging engineers, medical device combination product engineers, device development leads, human factors SMEs, design engineers and device analytical scientists.
Co-development team – drug product and device SMEs.
Quality Assurance
GCMC (Regulatory)
PGS – manufacturing sites and post-launch device team.
External designers and contract manufacturing organizations.

Education, Skills, and Experience

Education Requirements:

BSc

in an appropriate science & engineering discipline (e.g. chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with

a minimum of 5 years

of relevant experience in the pharmaceutical combination product and/or device industries
MSc

in the above disciplines with

a minimum of 5 years

of relevant experience

Required Experience and Knowledge:

Experience working under ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation
Proven expertise in

design control

and

risk management

for medical device combination products and/or medical devices
Familiarity with

Human Factors Engineering (Usability Engineering)
Understanding of

device assembly and manufacturing processes

Technical Skills Requirements

Working knowledge of relevant standards: ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU Medical Devices Regulation
Familiarity with EN 62366, EN 60601, and EN 62304
Strong adherence to established procedures with attention to technical detail and accuracy
Ability to work independently and collaboratively in cross-functional teams
Capable of handling multiple responsibilities and tasks simultaneously
Excellent communication and interpersonal skills
Proficient with general office software (e.g., Word, Excel, PowerPoint)
Knowledge of

Good Manufacturing Practices (GMP)

Physical Position Requirements

Sitting
Ability to travel
Driving license required

Competencies

Decisive:

Agile learner who synthesizes complex information to determine the best course of action
Focused:

Holds self and others accountable for consistently meeting needs of customers and stakeholders
Connected:

Builds effective professional relationships with internal and external stakeholders
Courageous:

Shows consistency between words and actions, gaining people's trust and respect
Resilient:

Adapts or shifts priorities in response to the needs of clients, constituents, or the organization

TekWissen® Group is an equal opportunity employer supporting workforce diversity.