product development manager - Bristol - £45k - £55k
Job Title: Product Development Manager
Location: Bristol, UK
Salary: £45,000 - £55,000 + benefits
I am working with a small company based in Bristol who are looking to hire an experience development manager to work closely with the production manager but in the near future take more of a technical operations lead.
What will you be doing?
The company need a candidate who can take up and manage their small-run, sub-contracted UK manufacturing and provide technical management of our design projects and technical file.
The Product Development Manager will take responsibility for the Company's Design Control activities, including management of sub-contracted manufacturing partners, test houses and other suppliers, to ensure ongoing compliance with applicable medical device regulations standards while gaining certification for new products and/ or territories.
, Managing the Company's approved suppliers, including sub-contract manufacturing partners
, Conducting supplier audits
, Coordinating testing of Company product (e.g.
, Initiating, managing and submitting design projects for both existing and new Technical Files
, Gaining regulatory approval for the Company's products in new markets, including the USA
, Managing budgets related to production and NPI activities
, Managing the Company's service engineering capability, including Field Service Engineers
Knowledge, Skills and Abilities:
, Proficient in the application of EU medical device regulations and related international standards including: ISO13485, Medical Device Directive, Medical Device Regulation, ISO14971.
Also technical standards, including ISO60601 and ISO62304.
, Demonstrable experience in establishing and successfully managing Design Projects for novel medical devices up to at least Class IIb
Nice to have skills but not essential:
, Experience of FDA design controls highly desired
, Familiarity with radio frequency technologies and or/imaging highly desirable
, Supplier audit training highly desirable
, Proficiency with CAD (e.g.
Solidworks or Solid Edge) desirable
, The ideal profile would be someone who has a PhD in medical imaging/ medical RF or a related field with a few years' experience as a project manager in an established manufacturer, or as a product development lead in an SME.
To apply for this role please call Danielle on 0117 428 0600 or email firstname.lastname@example.org
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