R&D Human Factor Engineer

Hi, greetings of the day

This is Rajitha. K from Intellectt Inc., working as a Technical Recruiter. Currently, we have an immediate opening with one of our direct clients, please find the below Job description and if interested kindly do share your resume at [email protected]

Role: Sr Manager, UI / Human Factors Engineering (Hybrid)

Location: Andover, MA 01810

Duration: Full-time

Description

• This individual must have significant experience in applying human factors in medical devices. (If your candidate has experience at a company as just a participate, in a Human Factors team solely... that will not suffice.
• This person must be able to be strong in their decisions with the expert knowledge they have and thrive in a fast-paced and high-stressed environment. (Deadlines are in their nature and should not rattle them. They need to be hungry to accomplish and make results happen!)
• They need to be adaptable and have the soft skills to know their audience. They need to be assertive when needed, but also have the ability to complete impactful, insightful and supporting conversations with patients.
• This person will understand and be able to confident in analyzing risks of the FDA process. And know what questions to ask, what resources or 3rd party suppliers will be necessary to execute the goal and will know when something is not within their means and should not be pursued.
• People, Priority and Project Management skills are huge! Very important. (During interview this will be asked in different ways. Examples will be needed so this person needs to be prepared and crisp. (It will be absolutely necessary that this individual will be able to confidently and competently be able to provide specific project and timeline details and examples of accomplishments, their method of thought & process, how they directed the internal and external resources for execution and how they overcame the hurdles and challenges that were faced. (Also, what lessons did they learn at the beginning of their Human Factors journey)
• The three core areas this person will be hitting on: Managing, Scheduling and Budgeting. (Experience in previous budgeting on projects is a MUST)
• The soft skills in this role matter! This person must be professional, but they MUST also have a backbone. If something is incorrect, they are trusting that this person is going to speak up no questions ask. This person is impactful and influential. (They had a previous candidate that met all the criteria, but had no backbone to direct and delegate they chose to reject this person because it is absolutely necessary in order for this team to be successful)
• This will not be this person's first time leading in Human Factors they need to have experience in managing people and direct reports in the concept, role and function.
• Although there are several industries that have Human Factor's needs they NEED to have experience in the MEDUCAL DEVICE INDUSTRY. (Make sure you identify what company in their work history reflects this).
• This person will need to also be a team player, a coach & mentor, and leader.
• This person has the ability and drive to enhance in the company. This is their passion embecta needs to hear that desire.
• Along with budgeting, they need to be able to master and understand which vendors will be able to execute which needs that are not internally available. They should be able to be familiar with the resources that are currently available and have the expertise to pinpoint what to look for, with the ones they are not so familiar with.
• This person is tactical yet very strategic - they must be able to budget and understand the current need and future need, as well as impact this will result it.

Below, are notes from the recruiting team for direct-hire placements. They have been working on this for quite some time but no luck in filling. They need our help, please find notes below for their guidance.

• Early exploration, talking to patients-- UX/UI focused work- customer satisfaction -not a priority.
• Trad. HF manager- functional owner of deliverables, part of FDA process, analyzing risks-
• Project Manager-Knows how to get it done through vendors but might not have done it themselves.
• Voice of human factors- done the work throughout the career-done it a lot
• Most experience HF person in team & contract agents (needs to grow this team- currently 3 grow to 6)
• Project management skills- time lines, deliverables, risks
• Player/coach-good at managing the internal team- managing external contractors.
• Bridge between key activist that happen outside our organization-key HF testing to a company-must monitor activity-reports, activities, testing etc.- their deliverables and make sure they are on time. Their Associate Director, R&D Systems and Human Factors Engineering, Systems Engineering is currently leading this now and is also the HM, taking it over from that HM (more than 50% of the job will be this role in beginning)
• Strong experience with relevant medical device standards, including IEC 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls.
• Manage our recruitment efforts-help us find patients.
• Understands how to deal with stakeholder and contract management and a good PM themselves, plan things out not rely on contracting company to do it themselves.
• Good role model, leader for all the other engineers
• (Individual Contributor but shown to lead a team OR has lead teams before, such as: lead or junior engineers)

Key Areas Of Experience

• Human Factors Validation Studies / Summative Studies
• HF/UE Report Writing
• URRA / uFMEA experience

Thanks & Regards,

Rajitha. K

Email: [email protected]

Direct Number: 732 532 2478; Ext :267

Qualifications

• This individual must have significant experience in applying human factors in medical devices
• (If your candidate has experience at a company as just a participate, in a Human Factors team solely... that will not suffice
• This person must be able to be strong in their decisions with the expert knowledge they have and thrive in a fast-paced and high-stressed environment
• They need to be adaptable and have the soft skills to know their audience
• They need to be assertive when needed, but also have the ability to complete impactful, insightful and supporting conversations with patients
• This person will understand and be able to confident in analyzing risks of the FDA process
• Examples will be needed so this person needs to be prepared and crisp. (It will be absolutely necessary that this individual will be able to confidently and competently be able to provide specific project and timeline details and examples of accomplishments, their method of thought & process, how they directed the internal and external resources for execution and how they overcame the hurdles and challenges that were faced. (Also, what lessons did they learn at the beginning of their Human Factors journey)
• (Experience in previous budgeting on projects is a MUST)
• The soft skills in this role matter!
• This person must be professional, but they MUST also have a backbone
• If something is incorrect, they are trusting that this person is going to speak up no questions ask
• This person is impactful and influential
• (They had a previous candidate that met all the criteria, but had no backbone to direct and delegate they chose to reject this person because it is absolutely necessary in order for this team to be successful)
• This will not be this person's first time leading in Human Factors they need to have experience in managing people and direct reports in the concept, role and function
• Although there are several industries that have Human Factor's needs they NEED to have experience in the MEDUCAL DEVICE INDUSTRY. (Make sure you identify what company in their work history reflects this)
• This person will need to also be a team player, a coach & mentor, and leader
• This person has the ability and drive to enhance in the company
• Along with budgeting, they need to be able to master and understand which vendors will be able to execute which needs that are not internally available
• They should be able to be familiar with the resources that are currently available and have the expertise to pinpoint what to look for, with the ones they are not so familiar with
• This person is tactical yet very strategic - they must be able to budget and understand the current need and future need, as well as impact this will result it
• Voice of human factors- done the work throughout the career-done it a lot
• Most experience HF person in team & contract agents (needs to grow this team- currently 3 grow to 6)
• Project management skills- time lines, deliverables, risks
• Strong experience with relevant medical device standards, including IEC 62366-1, ISO 13485, ISO 14971, FDA Guidance for Design Controls
• Good role model, leader for all the other engineers
• (Individual Contributor but shown to lead a team OR has lead teams before, such as: lead or junior engineers)
• Human Factors Validation Studies / Summative Studies

Responsibilities

• They need to be hungry to accomplish and make results happen!)
• And know what questions to ask, what resources or 3rd party suppliers will be necessary to execute the goal and will know when something is not within their means and should not be pursued
• People, Priority and Project Management skills are huge!
• The three core areas this person will be hitting on: Managing, Scheduling and Budgeting
• Early exploration, talking to patients-- UX/UI focused work- customer satisfaction -not a priority
• Trad
• HF manager- functional owner of deliverables, part of FDA process, analyzing risks-
• Project Manager-Knows how to get it done through vendors but might not have done it themselves
• Player/coach-good at managing the internal team- managing external contractors
• Bridge between key activist that happen outside our organization-key HF testing to a company-must monitor activity-reports, activities, testing etc.- their deliverables and make sure they are on time
• Understands how to deal with stakeholder and contract management and a good PM themselves, plan things out not rely on contracting company to do it themselves