Planet Pharma
Job Description
Additional position detail from the manager: Can you please confirm your top 3 skills sets required?
Experience with 3D CAD modeling software is required (preferably Creo), experience with troubleshooting design issues is preferred, experience with writing design validation/verification protocols and reports is preferred. Can you please confirm the 3 main responsibilities/day to day activities required for this role? The primary responsibility for this role will be 2D and 3D modeling of components and finished goods within our Cardiac Surgery product portfolio. This could include updates to existing parts or modeling new parts from scratch. This position will also help troubleshoot design issues and implement improvements while meeting our design and quality system requirements. This includes understanding product requirements and how those translate into design specifications. This role will also create design protocols and reports to validate design changes. What products (if any) will this role support? This role will support our Cardiac Surgery products, with a focus on our injection molded products. What is your target years of experience? 2-10 years Areas of responsibilities will include mechanical design, injection molding design and troubleshooting, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.
Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business. Work with cross functional teams to review, assess and implement design input for injection molded components. Ability to troubleshoot design issues, particularly understand injection molding related issues (i.e., process, material, design intent). Responsible for product system design and ensuring that products developed meet both internal and external customer requirements. Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices). Utilize design development, analysis and statistical tools, to include Creo, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Additional position detail from the manager: Can you please confirm your top 3 skills sets required?
Experience with 3D CAD modeling software is required (preferably Creo), experience with troubleshooting design issues is preferred, experience with writing design validation/verification protocols and reports is preferred. Can you please confirm the 3 main responsibilities/day to day activities required for this role? The primary responsibility for this role will be 2D and 3D modeling of components and finished goods within our Cardiac Surgery product portfolio. This could include updates to existing parts or modeling new parts from scratch. This position will also help troubleshoot design issues and implement improvements while meeting our design and quality system requirements. This includes understanding product requirements and how those translate into design specifications. This role will also create design protocols and reports to validate design changes. What products (if any) will this role support? This role will support our Cardiac Surgery products, with a focus on our injection molded products. What is your target years of experience? 2-10 years Areas of responsibilities will include mechanical design, injection molding design and troubleshooting, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.
Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business. Work with cross functional teams to review, assess and implement design input for injection molded components. Ability to troubleshoot design issues, particularly understand injection molding related issues (i.e., process, material, design intent). Responsible for product system design and ensuring that products developed meet both internal and external customer requirements. Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices). Utilize design development, analysis and statistical tools, to include Creo, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.