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Biocompatibility Consultant III

In Massachusetts / United States

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Biocompatibility Consultant III   

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JOB TITLE:

Biocompatibility Consultant III

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Andover Massachusetts / United States

JOB DESCRIPTION:

BIOCOMPATIBILITY CONSULTANT III

The Senior Biocompatibility Consultant, is an integral resource on NPD project teams, supporting the delivery of biological evaluations of S+N medical devices in compliance with relevant internal S+N procedures and external standards regarding biocompatibility. As a functional expert, the role holder is responsible for reviewing scientific data, designing test strategies & contracting out laboratory work, producing reports and representing Biocompatibility on cross-functional project teams.

The role holder provides biocompatibility information to support product quality, design control and regulatory activities with a minimal level of guidance from senior colleagues or management. Must communicate effectively and influence the decisions taken by cross-functional project teams.

As an intermediate scientist, the role holder provides leadership on biocompatibility matters within project teams and functions as the biocompatibility lead on multiple projects. The role holder builds relationships outside of the project team and uses these to influence project outcomes.

The role holder works on projects with moderate complexity and impact, coordinating cross-functional work packages and exercising judgement within defined procedures, as well as applying knowledge and experience to create new procedures. Receives minimal to no guidance for routine tasks.

The role holder is a functional expert who can advise on matters relating to biocompatibility which may include: toxicological risk assessment, chemical characterisation, biological safety testing and biocompatibility standards & regulations.
There are no direct managerial responsibilities but they train and mentor staff informally.

Responsibilities:

- (50%) Project Delivery – Supports the delivery of designated projects by authoring biological evaluation plans & reports, reviewing material & analytical data, managing external contract testing programmes and conducting toxicological risk assessments.

- (20%) Current Product Support – Provides ongoing biocompatibility support for current products which may include: evaluating material changes and updating biocompatibility reports for change control projects; working with Regulatory Affairs to create and execute biocompatibility plans for product launch into additional markets; conducting biocompatibility risk assessments for Quality-related events e.g. field safety; providing claims support; remediating existing biocompatibility documentation in accordance with updated standards and regulations as required.

- (10%) Functional Expertise – Develops and maintains an understanding of the state of the art regarding biological evaluation of medical devices and makes recommendations internally on updates to current methods and working practices. Reviews and approves biocompatibility reports. Represents Biocompatibility in audits and interactions with regulatory bodies.

- (5%) Technical Coaching - Provide coaching, training and mentoring to junior staff.

- (15%) Other requirements including: to perform all activities in compliance with relevant GMP and Quality Systems standards; to apply high standards of occupational Health & Safety in the workplace; to comply with company policy and procedures; to undertake training applicable to the role, to undertake other biocompatibility-related activities as required.

Location: Andover, MA USA

Education:

BS in engineering or science related field +4-years of related experience.
Or
MS in engineering or science related field +2-years of related experience.
Or
PhD in engineering or science related field.

Licenses / Certifications: Job holder pursues internal and external training opportunities in the field of biocompatibility and toxicology. May be working towards an additional qualification / certification relating to toxicology, e.g. European Register of Toxicologists (ERT), DABT or equivalent.

Experience: Extensive relevant work experience in a commercial environment.
Working knowledge and experience of biocompatibility testing, standards and best practice.

Competences: Strong organisational, prioritisation and communication skills.
Evidence of accurate analysis of data. Authorship or co-authorship of peer-reviewed manuscripts and abstracts preferred.

Position Details

POSTED:

Apr 20, 2022

EMPLOYMENT:

INDUSTRY:

Health Care

SNAPRECRUIT ID:

S164469600799936

LOCATION:

Massachusetts / United States

CITY:

Andover

Job Origin:

Jobsrus_organic_feed

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Biocompatibility Consultant III    Apply

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BIOCOMPATIBILITY CONSULTANT III

The Senior Biocompatibility Consultant, is an integral resource on NPD project teams, supporting the delivery of biological evaluations of S+N medical devices in compliance with relevant internal S+N procedures and external standards regarding biocompatibility. As a functional expert, the role holder is responsible for reviewing scientific data, designing test strategies & contracting out laboratory work, producing reports and representing Biocompatibility on cross-functional project teams.

The role holder provides biocompatibility information to support product quality, design control and regulatory activities with a minimal level of guidance from senior colleagues or management. Must communicate effectively and influence the decisions taken by cross-functional project teams.

As an intermediate scientist, the role holder provides leadership on biocompatibility matters within project teams and functions as the biocompatibility lead on multiple projects. The role holder builds relationships outside of the project team and uses these to influence project outcomes.

The role holder works on projects with moderate complexity and impact, coordinating cross-functional work packages and exercising judgement within defined procedures, as well as applying knowledge and experience to create new procedures. Receives minimal to no guidance for routine tasks.

The role holder is a functional expert who can advise on matters relating to biocompatibility which may include: toxicological risk assessment, chemical characterisation, biological safety testing and biocompatibility standards & regulations.
There are no direct managerial responsibilities but they train and mentor staff informally.

Responsibilities:

- (50%) Project Delivery – Supports the delivery of designated projects by authoring biological evaluation plans & reports, reviewing material & analytical data, managing external contract testing programmes and conducting toxicological risk assessments.

- (20%) Current Product Support – Provides ongoing biocompatibility support for current products which may include: evaluating material changes and updating biocompatibility reports for change control projects; working with Regulatory Affairs to create and execute biocompatibility plans for product launch into additional markets; conducting biocompatibility risk assessments for Quality-related events e.g. field safety; providing claims support; remediating existing biocompatibility documentation in accordance with updated standards and regulations as required.

- (10%) Functional Expertise – Develops and maintains an understanding of the state of the art regarding biological evaluation of medical devices and makes recommendations internally on updates to current methods and working practices. Reviews and approves biocompatibility reports. Represents Biocompatibility in audits and interactions with regulatory bodies.

- (5%) Technical Coaching - Provide coaching, training and mentoring to junior staff.

- (15%) Other requirements including: to perform all activities in compliance with relevant GMP and Quality Systems standards; to apply high standards of occupational Health & Safety in the workplace; to comply with company policy and procedures; to undertake training applicable to the role, to undertake other biocompatibility-related activities as required.

Location: Andover, MA USA

Education:

BS in engineering or science related field +4-years of related experience.
Or
MS in engineering or science related field +2-years of related experience.
Or
PhD in engineering or science related field.

Licenses / Certifications: Job holder pursues internal and external training opportunities in the field of biocompatibility and toxicology. May be working towards an additional qualification / certification relating to toxicology, e.g. European Register of Toxicologists (ERT), DABT or equivalent.

Experience: Extensive relevant work experience in a commercial environment.
Working knowledge and experience of biocompatibility testing, standards and best practice.

Competences: Strong organisational, prioritisation and communication skills.
Evidence of accurate analysis of data. Authorship or co-authorship of peer-reviewed manuscripts and abstracts preferred.


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